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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tsyunhehkwa 15-Feb-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Minneapolis District

240 Hennepin Avenue

Minneapolis MN 55401-1999

Telephone 612-334-4100

February 15, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 23

William Gollnick

Tribal General Manager

Tsyunhehkwa

720 1 Seminary Road

P.O. Box 365

Oneida, Wisconsin 54115

Dear Mr. Gollnick:

An inspection of your low acid canned food and acidified food processing plant,

Tsyunhehkwa (FCE 02469)) was conducted by an investigator of the Food and

Drug Administration from August 15 - 20, 2001. At the conclusion of the

inspection Ms. Carol Elm was presented with a form FDA-483 listing serious

deviations from Title 21 of the Code of Federal Regulations, Parts 108, 113 and 114

(21 CFR 108, 113, and 114). These sections cover cannery Emergency Permit

Control (108), the Good Manufacturing Practices for Low-Acid Canned Foods (113),

and Good Manufacturing Practices for Acidified Foods (114). By virtue of these

deficiencies, the products processed at your facility are adulterated within the

meaning of Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug and

Cosmetic Act (the Act). Specifically, our investigation found:

1. Failure to handle deviations less than scheduled processes per 21 CFR 113.89. Records reviewed for production on 12/ 14/00 (Retort # 1, [redacted] minutes short), 3/13/01 [redacted] degrees low), and 3/29/01 [redacted] minutes short) revealed processing deviations. Your firm did not have these deviations evaluated by a processing authority nor were the products appropriately reprocessed. In addition, processing deviations occurred on 10/18/00, 1l/6/00, 1l/15/00, l/9/01, 3/28/01 and 6/15/01 when the retort

temperature dipped below [redacted] degrees F.

2. Failure to file a process for a low-acid food, Corn Soup with Pork in pint jars,

or for acidified foods such as dill pickles, hamburger dills, bread-and-butter pickles and pickle relish as required by 21 CFR 108.35(c)(2) and 108.25(c)(2), respectively.

3. Failure to test and record equilibrium pH in acidified foods according to 21

CFR 114.80(a)(2).

4. Failure to follow the process times specified in the filed process required by

21 CFR 108.35(c)(3).

5. Failure to maintain required thermal records required by 21 CFR 108.35(h)

and 21 CFR 113.100.

6. Failure to measure and record initial temperatures for the thermal process

required by 21 CFR 108.35(h) and 21 CFR 113.87(c).

7. Failure to maintain a deviation file or log as required by 21 CFR 108.35(d)

and 21 CFR 113.89.

8. The process used to produce Corn Soup with Pork on March 13, 2001, was

not established by a qualified expert according to 21 CFR 108(c)(2)(ii) and 2 1

CFR 113.83.

9. Failure to establish and maintain container closure examination records required by 21 CFR 108.35(h) and 21 CFR 113.60.

10. Thermal processing records have not been reviewed consistently by management for completeness within one working day as required by 21 CFR 113.100(b).

11. Failure to take measures to prevent unauthorized changes in adjustment of the temperature recording charts as required by 21 CFR 113.40(a)(2).

12. Identification codes on thermally processed low-acid canned foods and acidified foods do not identify the location where produced nor the contents as required by 21 CFR 113.60(c).

13. Temperature recording, charts are not always properly marked with identifying data such as cooker number, lot number, date of cook, etc., as required by 21 CFR 113.100(b)

You should take prompt action to correct these deviations. Failure to promptly

correct these deviations may result in regulatory action without further notice such

as seizure and/or injunctive relief.

You should notify this office within 15 working days of receipt of this letter of the

specific steps you have taken to correct the noted violations including an

explanation of each step being taken to prevent recurrence of similar violations. If

corrective actions cannot be completed within 15 working days, state the reason for

the delay and the time within which the corrections will be completed. Your reply

should be directed to Compliance Officer Tyra S. Wisecup at the address indicated

on the letterhead.

Sincerely,

James A. Rahto

Director

Minneapolis District