The FDA’s Chobani Inspection Report

December 6, 2013 — By
Editors Note:  The following is a reprint of the FDA Chobani inspection report released following the September recall of the Chobani Greek Yogurt due to mold contamination.  The report is being discussed in the media due to comments therein (highlighted in orange text below) that imply the mold may have been discovered sooner than it was reported.  Idaho state officials reportedly deny the claim. Please note that many of the details in the report are redacted, as is common when information may be considered competitive in nature such as information directly related to recipes, suppliers, technology, trade secrets or other intellectual property.
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Establishment Inspection Report FEI: 3009726115

Chobani Idaho EI Start: 09/05/2013

Twin Falls, ID 83301 EI End: 09/18/2013

 

SUMMARY

This complaint/recall inspection of Chobani Idaho Inc. manufacturing ninety two various flavor and

container sizes of Greek Yogurt products was conducted by an ad hoc FACTS assignment

#8718055. There had not been a previous inspection conducted by FDA as the plant had initiated operations in November of 2012. Production processes were discussed and review of the corrective measures taken by the firm to correct the causes of the complaints and the recall were completed. This firm is licensed and routinely inspected by the Idaho State Department of Agriculture Bureau of
Dairying (ISDA).

 

At the start of this inspection the firm was producing various Greek Yogurt flavors on lines
[REDACTED] Equipment utilized for the processing and packaging of all products was evaluated.

Credentials were presented and Form FDA 482 was issued to Mr. Mark J. Flagg, Director of Operations, on September 05,2013 and to Mr. Hector Yzquierdo, Director of Manufacturing, (Mr. Y zquierdo does not have a middle initial) on September 16, 2013 the most responsible individual at the plant on those days of the investigation/inspection.  Mr. Mike Wiggs and Ms. Brook Legineche of ISDA were also involved in accompanying this investigation/inspection.

An exit interview was conducted on 09/18/2013 with Mr. Yzquierdo, Mr. Flagg, (b)(6),(b)(7)(C), Assistant Quality Control Manager, and Mr. Halil Ulukaya, Chief Manufacturing Officer,

(Mr. Ulukaya does not have a middle initial) representing Chobani, and with Ms. Legineche
representing ISDA. This inspection found minor GMP deficiencies and a Form FDA 483 was not
issued. A recap of the information utilized in the record review of the complaint/recall corrections
along with observations in the processing area was discussed. Mr. Flagg indicated that corrections
would be made as quickly as possible. No samples were collected and no refusals were encountered.

ADMINISTRATIVE DATA
Inspected firm: Chobani Idaho
Location: 3450 Kimberly Rd
Twin Falls, ID 83301
Phone: (208) 732-I700
FAX: No Fax number available
Mailing address: Same as location
Dates of inspection: 9/5/2013,9/6/2013, 9/16/20I3, 9/17/2013,9118/2013
Days in the facility: 5
Participants: Lester 0. Boian, Regional Milk Specialist
John W. Banks, Investigator

HISTORY
Chobani Idaho Inc. was incorporated in the state of ldaho early in 2012. It is a subsidiary of
Chobani, which has its corporate office at, 147 State Highway 320 Norwich, New York 138I5.
Chobani Idaho Inc. has a sister plant, Chobani New York Plant 669 County Road 25 New Berlin,
New York 13411. The firm has not had a previous FDA inspection and is not under a current
injunction or any warning letter correspondence from the state of ldaho or FDA.

Leading up to this inspection, on August 30, 2013 Chobani had initiated a “market withdrawal” of the products from Chobani Idaho Inc. production from all the warehouse and retail establishments they supply because of product quality issues. Chobani was able to contact and remove product from ninety five percent (95%) of all the distributors and retailers of their products. With concern of the general public
holding product, Chobani voluntarily issued a nationwide recall of all Chobani yogurt products
produced in Chobani Idaho Inc. plant with best buy code dates from September 11, 2013 to October
07, 2013. This recall created the need for this current assignment to investigate the activities

Chobani Idaho Inc. is utilizing to address the issues with their production.

INTERSTATE COMMERCE
Chobani Idaho Inc. production is approximately [REDACTED]% interstate commerce. In general the product is moved from the firm’s finished product cooler storage and is transported to a distributer’s cooler storage, two of the larger customers are [REDACTED] . Chobani Idaho Inc. does not control
any of the sales operation as sales are conducted from the Corporate Office Sales Group and the firm
does not have records of the distribution or to the companies the product is supplied.

JURISDICTION
Chobani Idaho Inc. manufactures Greek Yogurt only, with the exception of selling raw or
pasteurized cream, in variety of flavors and flavor combinations all with the Chobani label. (See
Exhibit #1) No labels were collected.

These products are all under the Grade A Interstate Milk Shippers (IMS) program and are routinely
inspected by Idaho State Department of Agriculture Dairy Bureau every three (3) months and the
pasteurization equipment is evaluated every three (3) months with timing of the pasteurizers every
six (6) months. The FDA standardized State Rating Officer completes a IMS listing rating of the
firm every two (2) years and the FDA Regional Milk Specialist will complete a Federal check rating
every three (3) years.

INDIVIDUAL RESPONSIBILITY AND PERSONS INTERVIEWED
Plant Personnel: Mark J. Flagg- Director of Operations

Mr. Flagg is responsible for all phases of the operation of the plant. All departments report to him and would make all he fmal decisions on day to day operations. He is the individual that would report directly to corporate on issues with the plant.

Hector Yzquierdo- Director of Manufacturing
Mr. Yzquierdo is the second in command to Mr. Flagg and has his responsibilities
when Mr. Flagg is not at the plant.

These plant personnel were available for the inspection and supplied the records and other
information requested. These personnel can be reached through the plant address and telephone
number.

The plant personnel had to establish permission from the corporate office to allow review of records
at the firm. Though permission was granted for the review of information, only a very few pieces of
information were allowed to be copied and removed from the firm. Chobani Corporate was not
willing to allow the information out of their control with concerns of the Freedom of lnformation
Act.

Corporate personnel:       Halil Ulukaya-Chief Manufacturing Officer
669 Country Road 25
New Berlin, New York 13411

Mr. Ulukaya has the corporate level responsibility over the Chobani Idaho Inc. plant
and the Chobani New York plant manufacturing and is the direct connection for Mr.
Flagg to Chobani Inc. Corporation.

Laura M. Zervic – Assistant General Counsel, Branding and Regulatory
Affairs

Chobani Global Holdings
147 State Highway 320
Norwich, New York 13815

Ms. Zervic is the liaison to the Seattle District office in the developing ofthe national
recall and the follow up of any actions for the recall.

Catherine A. King – General Counsel
147 State Highway 320
Norwich, New York 13815

MANUFACTURING/DESIGN OPERATIONS
Chobani Idaho Inc. produces only Greek yogurt in a variety of flavors and package sizes. See exhibit
#1 for a listing of the flavors and sizes produced.

The firm receives approximately [REDACTED] pounds of raw milk
per day directly from grade “A” IMS listed dairy farms in Idaho. Fruit and fruit flavoring is received
from [REDACTED]. (These companies were supplied verbally and the addresses
were not given.) Each of these companies can supply any of the fruit and/or fruit flavors for Chobani
Greek Yogurt products and are received at the plant in aseptic filled [REDACTED] containers (totes)
accompanied by a Certificate of Analysis (COA) indicating aseptic processing and filling ofthe fruit
or fruit flavors. Both Chobani Idaho Inc. and Chobani New York Plant receive their fruit and fruit
flavoring supplies from these companies in this manner.
Yogurt production process: Raw milk is separated [REDACTED]

The yogurt is then streamed to the fillers and [REDACTED] from the fillers to the caser and palletizer. Once palletized the yogurt is [REDACTED] chilled for [REDACTED] depending upon the packaging. Most yogurt cups will be in the [REDACTED] the pallets are moved to the finished
product cooler until transported.

Cream process: The cream from the milk separators is pumped to the raw cream storage tanks.
Cream can either be pasteurized and sold as pasteurized cream or sold as raw or heat treated cream.
Cream can be [REDACTED]

Primary Equipment: (Number of units-Description)

[REDACTED] – Milk High Temperature Short Time (HTST) pasteurization units (Including
[REDACTED] – Cream HTST unit
[REDACTED]  - Cold milk separator
[REDACTED] – Raw cream silos

Chobani Idaho Inc. is still in the construction stages and will be adding additional equipment as they
commission additional product lines

MANUFACTURING CODES
Chobani Idaho Inc. has a best buy date of sixty ( 60) days from the date of production on all of their
Greek yogurt products. Ink jet coding can be found on the lid, foil seal or the side of the container.

Coding is in two lines with the first line containing: Product name, Best buy date (day/month). The
second line contains: [REDACTED]

COMPLAINTS
This inspection ofChobani Idaho Inc. is an ad hoc FACTS assignment #8718055 directly related to
the national recall on September 05,2013 issued by Choban. The objective in this assignment was to
review the causes creating the need for the recall, installations of corrections made, on-going procedures to maintain corrections, if the scope of the recall is sufficient, and product testing utilized by the firm.

In July the routine Grade A sampling and testing samples taken by the Idaho Department of Agriculture (ISDA) from the Chobani Idaho Inc. production were visually noted, by the laboratory technician, that surface defects were present and additional testing was conducted noting a yeast like growth developing in the yogurt samples. ISDA followed-up with Chobani Idaho Inc. and the firm reviewed their keeping quality samples and found some samples beginning to show signs of swelling. The firm at this point believed it was a yeast problem and began an equipment cleaning regimentation but found the problem was being reduced but not stopped, so samples were sent [REDACTED], where a mold growth of Mucor circinelloides was plated. [text coloring  and emphasis added]

The firm then began a complete cleaning of the entire production facility starting with the air supply
replacing all hepa filters, cleaning all of the filter banks and duct work throughout the facility. Each
production room was cleaned from the ceiling to the floor including all the outside surfaces of
equipment and the floor drains. Processing equipment was cleaned in place (CIP) cleaned then
disassembled and checked for cleanliness, visual and swabbing. If not clean, the equipment was
hand cleaned and the CIP cycle adjusted, then the equipment was reassembled and CW cleaned
again. The cleaning process began with the raw side of production and progressed through the
packaging and cooling areas. In an e-mail from [REDACTED]
technician, to Mr. Flagg on March 08,2013, [REDACTED]had found [REDACTED]that were not yet in use, within the [REDACTED] area.

All of the valves in the [REDACTED] in the area were completely dismantled and thoroughly
cleaned, then reassembled and CIP cycles were evaluated and changed as needed. All [REDACTED]
were completely commissioned for CIP so all b 4 are included in the CIP cleaning cycles. These [REDACTED]are important in the product flow as [REDACTED]. With this clean-up and change in the system, the firm felt they were ready to continue full
production in the facility on 08112/2013.

The Idaho State Department of Agriculture (ISDA) continues to monitor the firm’s production and
will be completing the IMS routine inspection of the facility which includes disassembling and
inspecting equipment for cleanliness. The routine three month pasteurization equipment evaluation
and testing will be completed by ISDA in September and October as they come due for testing.

Records were reviewed on the cleaning regimentation of the firm. Title of records was “Action Items
for Corrections”. The records were by department and contained the item to be cleaned and
inspected, person responsible for the activity completion, completion date and the status of the item;
whether completed, needing continuous monitoring, or etc. Records demonstrated an exacting
coverage of the equipment and facility, with some of the items being on a continuous monitoring to
make sure the item continued to properly clean. Cleaning records from 8/12/2013 to 8/20/2013 were
carefully analyzed for any deviations from the protocol and all the records were found satisfactory.

CIP charts were reviewed and though there were a few anomalies found in the charts; length of time,
temperature, flow and chemical conductivity were established on each CIP chart reviewed to meet
the requirement of the equipment cleaned.

Chobani Idaho Inc. requested assistance form outside companies as they began the thorough
cleaning of the facility. was requested to have all of the construction personnel enter the building as the production workers are required, dressing in plant clothing and boots, going through the hand sanitation, and utilizing hair covering. All other entrances into the facility except the main entrance were closed. the firm’ s chemical provider, with help from [Redacted] the equipment installer, was
requested to evaluated the flow volumes, chemical strengths, length of CIP cycles and other values
of the CIP systems to improve the overall CIP cleaning of the production system. There were still
firm’ s chemical provider, with help from (b 4 the equipment installer, was requested

The firm routinely does sampling and testing of all the production lines every
production line, time the sample was take. Coliform testing has been changed [REDACTED] result on coliform creates a hold on that lot of product. A review of the lot proceeds for [REDACTED]pulling
samples to conduct coliform tests, and any positive[REDACTED]  the f to evaluated the flow volumes, chemical strengths, length of CIP cycles and other values of the CIP systems to improve the overall CIP cleaning of the production system. There were still [REDACTED] stress tests. Samples are identified as to (1:5 (4 hours by the Quality Control management and release or destruction of the product
is decided upon by the Quality Control Manager.

The stress testing is completed by [REDACTED] [REDACTED]. At the end of the periods
each sample is checked for container condition, product consistency, surface defects, smell and
flavor.

Environmental sampling is being conducted each [REDACTED] with locations in all areas of the facility to
validate the effectiveness of the cleaning program. Swabbing is completed on the floor areas, floor
drains and around equipment. Air plates are placed in different areas to check the air flow in the
rooms and the effectiveness of the hepa air supply system. The scope is aimed at [REDACTED]
[REDACTED] and additional swabbing is done on schedule plus or as corrective action is required due to a
presumptive positive or a suspect area of contamination. Quality control technicians are responsible
for completing the swabbing and sending swabs out for testing. The outside laboratory testing the
environmental sample is [REDACTED] A step by step protocol has been established by Chobani for the technicians to follow when swabbing. The protocol was reviewed along with testing records [REDACTED]. The protocol was very precise and regimented; Chobani was not willing to allow a copy ofthe protocol to leave the facility.

All the reports reviewed from the environmental testing were found negative, “not found”.
Chobani Corporate send several groups of the keeping quality samples from the beginning, middle
and end of the recall period, best buy date September 11 , 2013 to October 7, 2013, to[REDACTED]) to test for [REDACTED].

[REDACTED] . Chobani Corporate has informed the firm that all of

the samples were negative by phone, but records have not been supplied to the firm so there were no

records to review.

 

Chobani Idaho Inc. production sampling testing records were reviewed from 08/01/2013 through

08115/2013 on all production lines. Testing results showed sporadic low level counts in a few lines

up to 08/04/2013 where Lester 0. Boian found there were counts showing for both yeast and mold in

a majority ofthe lines from [REDACTED] through the next [REDACTED] sampling and testing that afternoon. In

discussion with management, Mr. Yzquierdo stated that was the concern that caused the discovery of

the b 4 in the[REDACTED] room. The sample testing records indicated that

after August 08, 2013 there were only two samples noted by John W. Banks that had counts of

concern (b) ( 4) yogurt sample taken at [REDACTED], production date of8/I0/2013 (best buy date

10/9/2013 ), had yeast count of:[REDACTED] and mold count of less [REDACTED], sample

taken at [REDACTED] (same production date) had yeast count of [REDACTED]  and less than LJ mold, sample at [REDACTED]

had yeast count of [REDACTED] and mold less than [REDACTED] and sample at [REDACTED] had yeast count of [REDACTED] and less than [REDACTED] mold.

 

Following the review of the sampling records, the keeping quality samples were reviewed in the

sample cooler. The review of the two varieties from the records with counts, the [REDACTED]

keeping quality samples were not found, and from the plant production records it was discovered

that the production was very small and the samples may have already been used. The [REDACTED]

[REDACTED] keeping quality samples were visually noted without defects. The review ofthe containers

up to the August 8  production date showed signs ofbulging in a majority of the sam~les, but after

August 8 production (best buy date of October 7′h) to the present day, September 161 ,

(b) (4} samples were showing signs of bulging. [REDACTED] yogurt samples best buy dated

10/8/2013 were slightly bulged on the top from line<bH41 and from line [REDACTED] And [REDACTED] oz yogurt samples best buy date 10/8/2013 were slightly bulging at the top from line(bH•l and line <bH41 .

(b)(6),(b)(7)(C) commented that he would make sure that Quality Control would conduct a review of the

production those two products, and the two products noted in the record review.

 

OBJECTIONABLE CONDITIONS AND MANAGEMENT’S RESPONSE

There was no previous inspection by FDA of this facility so there are no previous objectionable

conditions to review. No form FDA 483 was issued for this inspection.

 

REFUSALS

No refusals were encountered.

GENERAL DISCUSSION WITH MANAGEMENT

From the inspection conducted by Lester 0. Boian on 09/05/2013 the following notes were made:

only [REDACTED]

 

Inside of filler on line #1 overhead piping and filler head contained product residue on outer surface.

(Improve hand cleaning of filler outer surfaces)

Mr. Yzquierdo immediately directed an employee to hand clean the filler prior to use, and it was

completed during the inspection.

 

Filler on line #2 had condensate forming on the overhead piping. No dripping noted (Improve the air

flow inside the filler to eliminate condensate)

Mr. Flagg notified the engineering staff and they were investigating the hepa air flow into the filler.

Mr. Flagg indicated they would notify ISDA when completed. (Lester 0. Boian reviewed the filler

on 09/ 17/ 13 and found it satisfactory)

 

Connector hoses from the fruit totes to the [REDACTED] were kinked and some lying on the floor. (Initiate station positioning of the totes to limit length ofconnector hoses to be short as possible to help in

eliminating kinking and touching the floor) Mr. Flagg indicated that he would get with the engineers within a week and begin developing a means to direct the placing ofthe fruit/fruit flavor totes in a approximate location each time they are

positioned at the [REDACTED]sites. [REDACTED]

 

Product surfaces of equipment available for inspection were found satisfactory.

Discussions were conducted with the personnel noted in the Responsibility section above. Due to the

nature ofthis ad hoc FACTS assignment inspection, the general discussion was centered on the

discovery ofthe information that is noted in the Complaints I Product Defects section above.

 

ADDITIONAL INFORMATION

There is no additional information beyond what was provide above.

 

SAMPLES COLLECTED

No samples were collected.

 

VOLUNTARY CORRECTIONS

Mark Flagg, Director ofOperations, stated that all of the staffat Chobani Idaho Inc. was concerned

about the defe.cts that have plagued their yogurt products. They are dedicated to correct anything that

comes up and will make quick corrections on the plant objectionable observations noted above.

 

EXHIBITS COLLECTED

9 of 11 Establishment Inspection Report FEI: 3009726115

Chobani Idaho EI Start: 09/05/2013

Twin Falls, ID 83301 EI End: 09/18/2013

Exhibit #I (Pages 1-4)-Chobani Inc. Voluntary Recall Notice

Exhibit #2 -Corporate and New York plant address

Exhibit #3 – Laura Zervic address

Exhibit #4 (Pages 1-9)-Chobani (I:)) (4) Line’tt>H4

) Filler Clean Sheet

 

ATTACHMENTS

Attachment #I-Form FDA 482 date 09/05/2013

Attachment #2 – Form FDA 482 dated 09/16/2013

FMD-145

Mr. Halil Ulukaya

Chief Manufacturing Officer

669 Country Road 25

New Berlin, New York 13411

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