| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human ServicesMarch 11, 2011
WARNING LETTER NO. 2011-NOL-10
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Eric J. Blanchard, Secretary/Co-Owner
Cajun Crab, LLC
6022 Bayouside Drive
Chauvin, Louisiana 70344
Dear Mr. Blanchard:
On November 3-6, 2010, U.S. Food and Drug Administration investigators inspected your seafood processing facility, located at 6022 Bayouside Drive, Chauvin, Louisiana. We found 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 which complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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 United States Code (USC) 342(a)(4)]. Accordingly, your ready-to-eat crabmeat products are adulterated because they have been prepared, packed, or held under insanitary conditions whereby they 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 on FDA’s Internet home page at www.fda.gov.
Your significant violations were as follows:
1.You must implement the monitoring procedures and frequency listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of (b)(4) with a frequency of (b)(4) at the (b)(4) critical control point (CCP) to control pathogen growth and toxin formation as listed in your HACCP plan for fresh crabmeat. Specifically, your crab cooling monitoring record, dated November 4, 2010, revealed the last internal crab temperatures of batches 1 and 2 were determined 4 hours, 15 minutes and 2 hours, 55 minutes, respectively, after they were placed in the cooler. The internal crab temperatures at those times were recorded as 42ºF and 44ºF. Consequently, your firm is not monitoring temperatures during the (b)(4) to ensure the temperatures reach (b)(4), and monitoring again after an additional (b)(4) to ensure the temperatures are (b)(4) or below as required by your HACCP plan.
2. You must have a HACCP plan that, at a minimum, lists the critical limits which 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 point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for fresh crabmeat lists a critical limit of (b)(4) at the (b)(4) CCP which is not adequate to control pathogen growth and toxin formation. When cooked crabmeat is handled significantly while at internal temperatures above 70ºF, and further processing will occur after the cooked crabs are cooled, we recommend that processors limit the total time to 4 hours at temperatures above 50ºF with no more than 2 of those hours at temperatures above 70ºF in order to control pathogen growth.
3. 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 fresh crabmeat at the (b)(4) CCP, (b)(4) CCP, (b)(4) CCP, and (b)(4) CCP to control pathogen growth and toxin formation is not appropriate. The instructions listed in your corrective action plan do not state what action will be taken to correct the cause of the deviation at each of these critical control points, and does not provide your actions regarding the product after it has been evaluated and determined to be unsafe.
We are aware you promised to correct the deviations noted at the conclusion of the inspection and we received your letter on November 16, 2010, addressing the observations listed on the Form FDA 483, Inspectional Observations, issued to you on November 6, 2010. We have evaluated your response, and find you have not provided supporting documentation demonstrating you have completed the corrective actions.
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links on FDA’s home page at www.fda.gov.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products 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 steps you are taking to correct these violations. You should include in your response documentation, such as your revised HACCP plans, HACCP monitoring records, and sanitation records or other useful information which would assist us in evaluating your corrections. If corrective action cannot be completed with fifteen (15) working days, state the reason for the delay and timeframe with in which the correction will be completed.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 219-8818 extension 103.
Sincerely,
/s/
Kimberly L. McMillian
Acting District Director
New Orleans District
Enclosure: Form FDA 483 dated November 6, 2010
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