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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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May Food Supply, Inc. 07-Dec-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda, CA 94502-7070

Telephone: 510-337-6700

VIA FEDERAL EXPRESS

Our Reference: 2954044

December 7, 2001

WARNING LETTER

John Cheung, President/CEO/CFO

May Food Supply Inc.

1350 San Mateo Avenue

South San Francisco, California 94080

Dear Mr. Cheung:

On November 5 and 7, 2001, we inspected your seafood processing facility located at

1350 San Mateo Avenue, South San Francisco, California and found that you have

serious deviations from the Seafood HACCP regulations in Title 21, Code of Federal

Regulations, Part 123 (21 CFR 123). These deviations cause your Dungeness crabs,

which are imported from- to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and cosmetic Act (the Act), in that the products have been prepared, packed, and held under insanitary conditions whereby they may be rendered injurious to health. You may find the Act and the Seafood HACCP regulations through links in FDA?s home page at www.fda.gov.

Your serious HACCP deviations are as follows:

1. You must have product specifications that are designed to ensure that the fish and

fishery products you import are not injurious to health to comply with 21 CFR

123.10. However, your firm does not have product specifications for Dungeness crabs imported from [redacted].

2. You must implement an affirmative step which ensures that the fish and fishery

products you-import are processed in accordance with the Seafood HACCP

regulations to comply with 21 CFR 123. 12(a)(2)(ii). However, your firm did not

perform an affirmative step for Dungeness crabs exported by [redacted].

We observed the above-mentioned HACCP deviations during two previous FDA

inspections of your facility in November 1998 and August 1999. We discussed your

deviations by correspondence dated January 20, 1999. A copy of 21 CFR 123, Fish &

Fishery Products, is enclosed for your ready reference. We recommend that you review

21 CFR 123.12, Special requirements for imported products.

During the current inspection, we discussed with you the following deviations from the

Current Good Manufacturing Practices, 21 CFR 110:

  • Accumulated debris and old equipment clutter that were observed in several areas of the facility which needed to be removed and the areas cleaned.
  • Rusted ice machine pipe in one of the coolers.
  • Dripping water from a light fixture in a second cooler.
  • Need for cleaning and sanitation of the second cooler because of off odors.

At the conclusion of the inspection, the seafood deviations were listed on Form FDA 483

(Inspectional Observations) and discussed with Raymond C. Chang, Manager. A copy of

this form is enclosed for your ready reference. This list is not meant to be an all-inclusive

list of violations. It is your responsibility to ensure that all seafood products processed

and distributed by your firm are in compliance with the Act and all requirements of the

federal regulations.

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

the deviations noted may result in regulatory action without further notice. Such action

includes seizure and/or injunction. In addition, FDA may detain your imported seafood

products without examination.

Please notify this office in writing within fifteen(15) working days of receipt of this

letter of the specific steps you have taken to correct these violations, including an

explanation of each step taken to prevent their reoccurrence. You response should

include copies of any available documentation demonstrating that corrections have been

made. If corrections cannot be completed within 15 working days, state the reason for

the delay and the time frame within which the corrections will be completed.

Your response should be directed to: Ms. Harumi Kishida, Compliance Officer, U.S.

Food and DnJg Administration, 1431 Harbor Bay Parkway, Alameda, C-A94502-7070.

If you have any questions regarding any issue in this letter, please contact Ms. Kishida at

(510) 337-6824.

Sincerely,

Dennis K. Linsley

District Director

San Francisco District