Inspections, Compliance, Enforcement, and Criminal Investigations
Bobby Chez, Inc. 11/17/10
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) 331-4908
November 17, 2010
RETURN RECEIPT REQUESTED
Robert E. Sliwowski, President
Bobby Chez, Inc.
1990 Route 70 East
Cherry Hill, NJ 08034
Dear Mr. Sliwowski:
We inspected your seafood processing facility, located at 1990 Route 70 East, Cherry Hill, NJ from August 10, 2010 through August 24, 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 (21 CFR 123). 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 crab cakes (par-cooked), crab cakes (non par-cooked), seafood salad, lobster pot pies, lobster mashed potatoes, shrimp puffs, and coconut shrimp are adulterated, in that they have been prepared, packed, or held under 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.
We acknowledge your written response to the August 2010 inspection received by our New Jersey District on October 1, 2010. The agency has reviewed your response; however, your response does not adequately address the violations as noted below.
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(a), and (b). However, your firm does not have HACCP plans for:
a. Seafood salad, crab cakes (non par-cooked), lobster mashed potatoes and lobster pot pies to control the potential food safety hazards of pathogen growth and toxin formation, specifically, Clostridium botulinum, Staphylococcus aureus, and Bacillus cereus, and undeclared allergens;
b. Shrimp puffs and coconut shrimp, to control the potential food safety hazards of undeclared allergens, undeclared sulfites, and pathogen growth and potential toxin formation, specifically, Clostridium botulinum, Staphylococcus aureus, and Bacillus cereus.
We acknowledge your written response to the August 2010 inspection received by New Jersey District on October 1, 2010. The agency has reviewed your response; however, your response does not adequately address this violation. You did not provide HACCP plans for coconut shrimp, lobster pot pies, lobster mashed potatoes, crab cakes (non par-cooked), seafood salad, or shrimp puffs.
2. 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)(1). However, your firm's HACCP plan for crab cakes (par-cooked) provided in your response lists monitoring procedures at the labeling critical control point that are not adequate to control undeclared allergens.
3. 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 (c)(2). 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, your firm's revised HACCP plan for crab cakes (par-cooked) does not list the processing steps after opening the pasteurized crabmeat containers until finished product storage for controlling the food safety hazard of pathogen growth and possible toxin formation, specifically, Staphylococcus aureus and Bacillus cereus. The FDA investigators observed that during your processing steps, beginning with opening cans of crabmeat through cooling the packaged par-cooked crab cakes, the crab cakes were held at temperatures both above and below 70°F for approximately three hours, with internal temperature of the product at 65°F after that time period.
Furthermore, on 08/10/2010, you were cooling crab cakes in a refrigeration unit that had an ambient air temperature that ranged from 52°F to 64°F.
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 procedures listed in your HACCP plan for crab cakes (par-cooked).
a. You did not measure the internal temperature of the crab meat at the receiving critical control point to control the hazard of pathogen growth and toxin formation. Specifically, an employee was observed using an infrared thermometer to measure the surface (external) temperature of canned pasteurized crab meat. Measuring the surface temperatures with an infrared thermometer may be an acceptable verification procedure under certain conditions where the temperatures during transit are known and documented. The practice needs to be included in your HACCP plan when those conditions are met.
b. Temperature monitoring at the critical control point of receiving was not conducted on 08/20/2009, 08/25/2009, or 08/27/2009.
c. You did not implement your procedure of a once daily temperature check at the critical control point of storage to control the hazard of pathogen growth and toxin formation.
You state that you have implemented these monitoring procedures listed in your HACCP plan for crab cakes, but you did not provide evidence, in the form of copies of actual critical control point monitoring records, to show that your firm has implemented this monitoring.
5. 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 of "provide wholesale customers with a list of ingredients including wheat, egg and milk" that is listed in the HACCP plan for crab cakes (par-cooked) at the labeling critical control point to control undeclared allergens is not appropriate. Corrective actions should ensure that unsafe product does not reach the consumer and correct the problem that caused the critical limit deviation.
6. You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of "Product maintained at or below 40 degrees" for crab cakes at the storage critical control point to control the hazard of pathogen growth and toxin formation. Specifically, you deviated from your critical limit on 09/09/2009, 03/25/2010, 04/20/2010, 05/26/2010, 06/17/2010, 07/27/2010, 08/10/2010, and 08/11/2010 and no corrective action was documented.
We acknowledge that you have documented corrective actions when you deviated from the critical limit of "Product maintained at or below 40 degrees" at the critical control point of storage. "However, the corrective actions are incomplete, in that, you only address the temperature deviation, and you do not evaluate whether products have been affected.
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: Kerry Kurdilla at the address listed above. If you have questions regarding any issues in this letter, please contact Ms. Kurdilla at (973) 331-4908.
New Jersey District Office