Inspections, Compliance, Enforcement, and Criminal Investigations
Eastern Treats Specialty Foods, Inc. 10/6/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
October 6, 2011
Eastern Treats Specialty Foods, Inc.
5626 Hansel Avenue
Orlando, FL 32809
Dear Mr. Rabassa:
We inspected your seafood processing establishment, located in Orlando, FL from September 13-15, 2011. 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 Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 crab cakes 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:
1. 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,
a. Your firm did not follow the monitoring procedure of “ Quality Control personnel will check and document product temperature using a calibrated thermometer for each delivery” at the receiving critical control point to control Clostridium botulinum listed in your HACCP plan for Crab Cake – Can Pasteurized Natural.
b. Your firm did not follow the monitoring procedure of “Quality Control personnel will monitor and document the calibrated digital continuous thermometer once daily” at the storage critical control point to control Clostridium botulinum listed in your HACCP plan for Crab Cake – Can Pasteurized Natural. Your firm failed to monitor this thermometer from July 1-6, 2011 and from August 3-12, 2011.
2. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not adequately record monitoring observations at the storage critical control point to control Clostridium botulinum listed in your HACCP plan for Crab Cake – Can Pasteurized Natural. Your firm failed to change the continuous weekly recording chart from August 8, 2011 through September 13, 2011. You recorded satisfactory results for cooler temperatures on your Operational Sanitation Checklists from August 16, 2011 through September 13, 2011.
We received your response dated September 29, 2011 to the Form FDA 483, Inspectional Observations, issued to and discussed with you at the close of the inspection on September 15, 2011. Although you have provided your amended HACCP plans to correct the associated observations (Observations 1 and 3), your failure to successfully implement your HACCP plans is evidenced by repeated observations from previous inspections. Therefore, your response to the citations above has been deemed inadequate.
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 U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724.
Ronnie E. Jackson
Acting Director, Florida District