Inspections, Compliance, Enforcement, and Criminal Investigations
Mary Ellen Maryland Crab Meat Company, Inc. 07-Feb-07
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 526-6008
RETURN RECEIPT REQUESTED
February 7, 2007
Ms. Aeyoung Kim
Mary Ellen Maryland Crab Meat Company, Inc.
2613 Fire Road
Egg Harbor City, New Jersey 08234
Dear Ms. Kim:
We inspected your seafood processing facility, located at 2613 Fire Road, Egg Harbor City, New Jersey on November 2, 3 & 14, 2006. We found that you have serious deviations from 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 Parts 123 & 110). In accordance with 21 CFR 123.6(g), the failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section, or to 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 &Cosmetic Act (the Act) (21 U.S.C. §342(a)(4)). Accordingly, your histamine producing fish such as your fresh tuna, mahi-mahi, escolar and your vacuum-packaged smoked fish, canned pasteurized crab meat, fresh crab meat, seafood salads and seafood soups are adulterated, in that 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 in FDA's home page at www.fda.gov.
Your significant violations were as follows:
- You must implement the record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and(c)(7). However, your firm did not record monitoring observations at the receiving critical control point to control histamine as listed in your HACCP plan for histamine producing fish. Specifically, your plan lists that you will maintain a receiving log to indicate monitoring for the presence of adequate ice at receipt. However, your receiving logs/records revealed that you received shipments of fresh mahi-mahi, tuna, marlin and escolar on at least thirty-one distinct occasions during the months of May through October, 2006. For each of these lots, you failed to record the adequacy of ice upon receipt per your HACCP plan. Similarly, during the same time period, the adequacy of ice during cooler storage was not documented as having been monitored.
- You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c) (4). However, your firm did not follow, and is not able to implement, the monitoring procedures and frequency related to the electronic alarm system at the storage critical control point to control pathogen growth/temperature abuse as listed in your HACCP plan for vacuum-packaged smoked fish, canned pasteurized crab meat, fresh crab meat, seafood salads and seafood soups. Specifically, your plan lists continuous temperature monitoring of the ambient air temperature of your cooler with the use of an automatic electronic monitor/alarm at the storage critical control point. However, your continuous monitoring consists solely of an audible alarm, which can only be heard in your firm's office area. Therefore, you have no assurance that temperature excursions have not occurred after normal business hours, during weekends or during days when your firm is closed. In addition to 24 hour continuous monitoring, FDA also recommends that a visual check of the instrument itself be conducted at least once per day.
- You must have and implement a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your HACCP plan for vacuum-packaged smoked fish, canned pasteurized crab meat, fresh crab meat, seafood salads and seafood soups lists inadequate monitoring procedures at the receiving critical control point to control pathogen growth and toxin formation. Specifically, your plan does not provide any means to adequately ensure that the critical temperature limit, i.e. [redacted]°F listed in your plan is consistently maintained during transit to your facility. Your shipping records indicate shipments of jumbo lump crab meat arriving from [redacted] and from [redacted] FDA recommends that when products such as those included-in your plan are in transit for extended time periods and/or from long distances such as these locations and are not shipped on ice or other cooling media, processors adopt a monitoring procedure or method that documents temperatures were continuously maintained at or below the critical limit during the entire duration of the transit period.
We acknowledge your response of November 28, 2006 wherein you indicate you have now calibrated the set temperatures for your audible alarm. However, your explanation of the corrections do not adequately address the issue associated with monitoring when employees are not at the facility, such as weekends and other times when your facility is not open for business. We further acknowledge receipt of your revised HACCP plan. However the revised plan you submitted which now combines multiple products, is inadequate in that it does not accurately identify the hazards to be controlled for these products. Moreover, the plan now lists monitoring procedures at the storage critical control point that are significantly different from the original plan(s) and which are inadequate when monitoring products that are not stored on ice or cooling media.
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: Richard Manney, Compliance Officer, at U.S. Food and Drug Administration, 10 Waterview Boulevard, Parsippany, New Jersey. If you have questions regarding any issues in this letter, please contact Mr. Manney at (973) 526-6008.
Douglas I. Ellsworth
New Jersey District