- Preferred Freezer Services Of Atlanta, LLC
- Issuing Office:
- Atlanta District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Atlanta District Office|
60 Eighth Street N.E.
Atlanta, GA 30309
October 23, 2015
DELIVERY SIGNATURE REQUESTED
John J. Galiher, CEO
Preferred Freezer Services
One Main Street
Chatham, NJ 07928
Dear Mr. Galiher:
We inspected your seafood processing facility, Preferred Freezer Services of Atlanta, LLC, located at 518 Forest Parkway in College Park, GA on July 2-8, 2015. 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, 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 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, the frozen shrimp that your firm repacks 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: Fourth Edition
through links in FDA's home page at www.fda.gov
Your significant violations were as follows:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish or fishery product you handle or process to determine whether there are food safety hazards which are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards identified, to comply with 21 CFR 123.6 (a) and (b).
Your firm receives frozen prepackaged shrimp, removes the shrimp from those packages, and then repacks the shrimp into other packaging. This operation meets the definition of “processing” as defined by 21 CFR 123.3(k)(1). Sulfiting agents, commonly utilized to prevent “black spot” on shrimp, are substances that are of particular concern with the frozen shrimp products you repack. Under provisions of the Act, a food is deemed misbranded, unless the label bears the common or usual name of each ingredient it contains. This listing of ingredients is important for people who need to avoid certain ingredients for health reasons. People sensitive to sulfiting agents can experience symptoms that can range from mild severity to life-threatening reactions. As such, your firm does not have a HACCP plan to control the food safety hazard of undeclared sulfiting agents associated with the shrimp you repack and we are not aware of controls that you have implemented for controlling the hazard. As a shrimp repacker, it is pertinent that your firm implement controls to routinely determine whether the shrimp you receive, repack, and further distribute contain sulfiting agents. In the event the products contain these agents, you must implement controls to ensure that the products are properly labeled as containing such prior to your firm distributing them.
We acknowledge receipt of your firm’s written response to the FORM FDA 483, Inspectional Observations, issued at the close of the inspection. That written response, dated 7/21/2015, was received from your firm’s corporate food safety & quality manager and the general manager of the College Park, GA location. For your reference, we have enclosed a photocopy of the FORM FDA 483 issued. Your firm’s written response this observation is inadequate because the updated HACCP plan provided with the response, entitled (b)(4)
, does not address the food safety hazard of undeclared sulfiting agents. Moreover, your HACCP plan appears to only relate to prepackaged frozen and refrigerated seafood products that your firm repacks into other cases, without opening those individual packages. It does not refer to the repacking operations where packages of frozen shrimp are opened, product removed, and then repacked into other finished product bags. Please refer to Chapter 19 of the FDA Fish and Fishery Hazards and Controls Guidance: Fourth Edition
(the Hazards Guide) for further information and guidance in determining the appropriate controls for your shrimp repacking operation. The Hazards Guide is available through links on FDA’s homepage at www.fda.gov
2. You must monitor the sanitation conditions and practices during processing with sufficient frequency to ensure, at minimum, conformance with Current Good Manufacturing Practices specified in 21 CFR 110 that are appropriate to the plant and the food being processed, to comply with 21 CFR 123.11(b). However, your firm did not document the monitoring of sanitation conditions and practices during the week of 2/23–27/2015. Additionally, review of available sanitation monitoring records and through verbal confirmation from an employee, it was revealed that some information, such as personnel initials and the time of the sanitation check, is routinely pre-filled and does not necessarily reflect the actual time that the operations occur.
In your firm’s written response to this observation, a commitment was made to completion of a daily sanitation inspection report when monitoring sanitation conditions and practices. The daily sanitation control record submitted with the response should provide for adequate documentation of the monitoring of the key sanitation areas, if properly implemented. The response did not address our concerns regarding pre-filled data on the forms. Information shall be entered on records at the time that it is observed and shall include the signature or initials of the person performing the operation.
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 the violation. 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 your reason for the 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: Lakisha N. Morton, Compliance Officer; 60-8th Street NE; Atlanta, GA 30309. If you have questions regarding any issues in this letter, please contact Mrs. Morton at 404-253-1285.
Ingrid A. Zambrana
cc: Roland A. Burnett, Jr., General Manager
Preferred Freezer Services of Atlanta, LLC
518 Forest Parkway
College Park, GA 30349