Airline Seafood, Inc. 3/16/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128

 

March 16, 2011

2011-DAL-WL-8

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Steve W. Berreth, Owner and President
Airline Seafood, Inc.
1841 Richmond Avenue
Houston, Texas 77098

Dear Mr. Berreth:

We inspected your seafood processing facility, located at 1841 Richmond Avenue, Houston, Texas 77098 on November 08 and 12, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).

Accordingly, your fresh refrigerated cooked ready-to-eat crabmeat stored in oxygen reduced packaging is adulterated, in that it been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:
 

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (b). However, your firm does not have a HACCP plan for fresh refrigerated cooked ready-to-eat crabmeat to control the food safety hazard of Clostridium botulinum.

2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor condition and cleanliness of food contact surfaces with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:

Empty plastic totes used to hold fresh refrigerated fish, cooked ready-to-eat crab meat and other seafood products were observed stored nested in the production room. An accumulation of material from previous processing was found on the handles of the totes. The totes were wet and found to be wet during storage which could contribute to bacterial growth on the surface of the container.

3. You must have a HACCP Plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3(c) as the "maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for Histamine Prone Fish lists a critical limit of (b)(4) at the receiving critical control point that is not adequate to control histamine formation. For fish that are delivered refrigerated, FDA recommends all lots received are accompanied by transportation records that show that the fish were held at or below 40°F throughout transit; or for fish under ice chemical cooling media; there is an adequate quantity of ice or other cooling media at the time of delivery to completely surround the product. Also, due to the inadequate critical limit, reconsideration of your monitoring, record-keeping, and verification procedures, as well as your corrective action plans, may be warranted for the critical control point when appropriate modifications to your critical limits are made."

4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for Histamine Prone Fish at the Storage Critical Control Point to control Histamine hazard is not appropriate.
 

Specifically, your corrective action indicates that internal temperature checks of un-iced fish are performed (b)(4) which is adequate when the firm is operation. However, by conducting these checks (b)(4) leaves the fish vulnerable to temperature abuse when the firm is (b)(4) and does not provide a reliable assurance of the temperature over time. If the fish are ever observed to have insufficient ice, and it has been greater than (b)(4) since the last recorded check, then FDA recommends rejecting the lot.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

 

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Ronda Loyd-Jones at 4040 North Central Expressway, Suite 300, Dallas, Texas. If you have questions regarding any issues in this letter, please contact Ronda Loyd-Jones at 214-253-5242.

Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 

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