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Department of Health and Human ServicesFEI:3003700093
WARNING LETTER
CMS #109809
July 21, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Francesco Marra, President and CEO
Euro Gourmet, Inc.
10312 Southard Drive
Beltsville, MD 20705-2107
Dear Mr. Marra:
We inspected your seafood processing facility, located at 10312 Southard Drive, Beltsville, Maryland, on March 8-9, 15, 18-19, 2010. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, 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 refrigerated ready-to-eat pasteurized crabmeat in hermetically sealed cans and scombroid fishery products, such as your refrigerated ready-to-eat marinated anchovies, are adulterated in that these products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or 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.
The significant violations were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that at a minimum lists the critical control points to comply with 21 CFR 123.6 (a) and (b). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However:
a. Your firm's HACCP plan for crab, which includes fresh (cooked) and pasteurized crabmeat, does not list the critical control point of receiving for controlling the food safety hazards,
i. For cooked crabmeat, of pathogen growth and toxin formation and
ii. For pasteurized crabmeat, Clostridium botulinum growth and toxin formation.
b. Your firm's HACCP plan for "Product Type: Scrombotoxin (sic)," such as your marinated anchovies, does not list the critical control points of refrigerated storage for controlling the food safety hazards of pathogen growth and toxin formation, including toxin formation due to scombrotoxin (histamine) formation.
2. 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 Part 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 HACCP plan for "Product Type: Scrombotoxin (sic)," such as your marinated anchovies, lists critical limits at the receiving critical control point that are not adequate to control pathogen growth and toxin formation, including scombrotoxin (histamine) formation. Specifically, your HACCP plan lists critical limits in part, "Receiving" critical control point of "Kept At (b)(4) or Below (b)(4) Or Higher." As listed, products above 38°F would be accepted with no maximum temperature limit. In addition, FDA recommends these products be kept at or below 40°F, rather than the 45°F listed in your plan. Further, the critical limit does not state whether these temperatures are product internal temperatures, product external temperatures, or ambient
temperatures during transport.
3. You must have 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:
a. The HACCP plan for "Product Type: Scrombotoxin (sic)," such as your marinated anchovies, lists a monitoring a procedure, "Upon Receipt 2 Twice Daily Temp (sic) Checks," at the receiving critical control point that is not adequate to control pathogen growth and toxin formation, including scombrotoxin (histamine) formation. FDA recommends that you monitor transport conditions (e.g. adequacy of cooling media or transport temperatures, i.e., time/temperature data logs) to ensure that your products have been held under safe conditions throughout transport.
b. The HACCP plan for crab lists a monitoring procedure and frequency for pasteurized crabmeat, "Recording Storage Area Temperatures... Continuous Recording Thermometer" at the storage critical control point that is not adequate to control the hazard of Clostridium botulinum growth and toxin formation. FDA recommends a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly.
4. 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 the monitoring procedure and frequency, "Presence of adequate ice ...Visual check for presence of adequate ice...Every 4 hours of operation...Or-Recording Storage area Temperatures. Continuous recording thermometer. .." listed in your HACCP plan for crab, which includes pasteurized crabmeat, at the storage critical control point to control Clostridium botulinum. During the inspection, the investigator observed that your coolers are not equipped with a continuous temperature recording device. In addition, the investigator observed that you do not store pasteurized crabmeat iced.
5. Since you choose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your HACCP plans list corrective actions that are not appropriate as follows:
a. The corrective action listed in your HACCP plan for crab, which includes fresh (cooked) and pasteurized crabmeat, at the storage critical control point is not appropriate because it does not address the source of the deviations and the corrective actions needed to prevent the deviations from re-occurring. In addition, the corrective action listed does not ensure that potentially adulterated products do not enter into commerce.
b. The corrective action listed in your HACCP plan for "Product Type: Scrombotoxin (sic)," such as your marinated anchovies, at the receiving critical control point is not appropriate because it does not address the source of the deviations and the corrective actions needed to prevent the deviations from re-occurring. In addition, the corrective action listed does not ensure that potentially adulterated product do not enter into commerce.
In addition, we suggest that you assess all of your corrective action plans to ensure that, in addition to holding product for evaluation, the corrective actions listed in your HACCP plans correct the causes of the deviations and prevent the distribution of adulterated products into commerce.
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 123) and the Current Good Manufacturing Practice regulation (21 CFR 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: Randy F. Pack, Compliance Branch Director, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions regarding any issue in this letter, please contact Mr. Pack at 410-779-5417.
Sincerely,
/S/
Evelyn Bonnin
Baltimore District Director
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