Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
October 2, 2015
Mr. Leon “Pete” D. Bellamy
Gourmet Classic Salads, Inc.
240 East Bullard Avenue
Lake Wales, FL 33853
Dear Mr. Bellamy:
We inspected your seafood processing facility, located at 240 East Bullard Avenue, Lake Wales, Florida from June 9, 2015 to July 10, 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. 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, ready to eat seafood saladproducts are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay 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 note your response received July 15, 2015 in response to our request for additional supporting documentation to verify your corrective actions. We have the following concerns regarding your HACCP plan for ready to eat seafood salads.
Your 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 (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 HACCP plan for “Ready to Eat Seafood Salads” does not list the critical control points of
- Processing/mixing and blending of ready to eat seafood salads for controlling the food safety hazard of pathogenic bacteria growth and toxin formation.
- Distribution/shipping of your firm’s ready to eat seafood salads for controlling the food safety hazard of pathogenic bacteria growth and toxin formation. You stated to the investigator that deliveries take in excess of (4) hours to complete.
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)(4). However, your firm’s HACCP plan for your Ready to Eat Seafood salads, lists a monitoring procedure and frequency at the (b)(4) CCP that is not appropriate.
- A “circular temperature recording device” that is used on (b)(4)
- A “quick check thermometer” that is monitored (b)(4) day.
For refrigerated storage, FDA recommends the use of equipment, on site, capable of continuously monitoring and recording temperatures on a 24 hour a day/7 day a week basis, with a daily check of the record and a daily check of the equipment. A monitoring frequency of (b)(4) times a day does not provide an equivalent assurance of safety and does not account for storage of product overnight or during non-operational days (i.e. Holiday’s and weekends). Please refer to Chapter 12 of the Fish and Fishery Products Hazards and Controls Guidance for guidance on determining appropriate critical limits and monitoring procedures to control the food safety hazard of pathogenic bacteria growth and toxin formation for time temperature abuse during cooler storage.
We acknowledge your July 15, 2015 response where you state that you will install a temperature warning system. We will verify this corrective action at the next scheduled inspection of your firm.
3. You must implement the monitoring procedures that you have listed in your HACCP plan to comply with 21 CFR 123.6(b). However your firm did not follow the monitoring procedures/frequencies of metal inclusion for all trays listed in your HACCP plan for Ready to Eat Seafood Salads.
We note in your response dated July 15th that you state you will implement monitoring for metal inclusion at the beginning and end of production. We will verify this corrective action at the next scheduled inspection of your firm.
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:
Carla Norris, Compliance Branch
United States Food and Drug Administration
200 Winderley Place, Suite 200
Maitland FL, 32751
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
If you have questions regarding this letter, please contact Carla Norris, Compliance Officer, at 407-475-4730.
Susan M. Turcovski
Director, Florida District