Inspections, Compliance, Enforcement, and Criminal Investigations
Thomas Crab Company 28-Dec-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
December 28, 2006
Mr. Hixon D. Thomas, Owner
Thomas Crab Company
60 Evaley Road
Crawfordville, Florida 32327
Dear Mr. Thomas:
We inspected your seafood processing facility, located at 1629 Coastal Highway, Panacea, Florida 32346 on August 16-18, 2006. 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 (CGMP) 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, your ready-to-eat crabmeat products are adulterated, in that they have been prepared, packed, or held under these insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, these regulations and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
our 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, your firm did not follow the monitoring procedures at the Backing, Picking and Packing critical control point to control pathogen growth and toxin formation listed in your HACCP plan for cooked crabmeat. Specifically, your firm has ceased i.e., since February 10, 2006, monitoring the time parameters associated with exposure to un-refrigerated conditions.
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 cooked crabmeat lists a monitoring procedure and frequency at the Finished Product Cooler critical control point that is not adequate to control pathogen growth and toxin formation. Specifically, your plan lists that you will monitor cooler temperatures three times throughout the day. The FDA does not consider intermittent temperature checks during storage periods to be an adequate method of assuring that ready-to-eat cooked crabmeat is held at safe temperatures throughout storage. To ensure that the critical limit of 40°F at the cooler storage critical control point is consistently met, FDA recommends a method of continuous temperature monitoring such as a time/temperature data logger, recorder thermometer or a high temperature alarm with 24 hour monitoring. Thus the monitoring frequency would be continuous by the instrument itself with a visual check of the instrument at least once per day to assure it is properly functioning.
3. 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 record monitoring observations at the cooling "Cooked Crab Cooler" critical control point to control pathogen growth and toxin formation hazard listed in your HACCP plan for cooked crabmeat.
4. 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, all of your corrective action plans for cooked crabmeat are not appropriate because the HACCP plan does not describe the procedures that your firm will use to correct the cause of deviation/problem e.g. for the finished product storage critical control point repair of the cooler.
5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product as evidenced by [§123.11(b)(3)]:
> four employees observed without effective hair restraints and one employee wearing jewelry while picking and packing crabmeat,
> employees observed using a knife which was scratched and encrusted with a dark residue; and
> employees using a knife fitted with garden hose cover during crabmeat picking operations;
> the underside of picking and packing table rims were roughly cut and encrusted with residue from previous crabmeat processing operations; and
> the underside of picking and packing tables were found constructed with uncovered plywood.
Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces as evidenced by [§123.11(b)(7)]:
> the observation of an employee wiping their nose with a wadded paper towel and returned to picking crabmeat without washing or sanitizing their hands; and
> an employee picking crabmeat with a taped finger and ungloved hands.
Your firm failed to properly discard waste and debris such as crates, pipes, toilet, trash, old equipment and materials observed on grounds directly outside cooking room. Stagnant water was also observed in the same area directly adjacent to building [21 CFR 110.20(a)(1) and (3)]
Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants as evidenced by [§123.11(b)(5)]:
> the screened exterior wall of the eastern side of the cooking room had a large tear above the crab cooking kettles allowing possible access into the cooking room by insects, birds, and other pests, and
> your firm was found using an insecticide not permitted for use in food areas, food handling establishments or other areas where food is
commercially prepared or processed
Exclusion of pests from the food plant as evidenced by [§123.11(b)(8)]:
> rodent and live insect activity observed in processing areas and on food contact surfaces, during ready-to-eat fresh crabmeat manufacturing operations.
> Approximately one hundred (100) dried rodent excreta pellets were found beneath boxes of finished product containers on the floor in the packaging materials room.
> Your picking and packaging room operations supervisor reported previously killing a rodent running into the picking room.
> Live flies were observed during picking and packing operations, at least four flies were observed crawling on processing tables and finished product containers.
> Approximately six live ants were observed on the crabmeat weighing tables with exposed cooked crabmeat.
> Five ants were observed crawling in and on at least one open cup of crabmeat.
6 . You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain any sanitation monitoring records. Our investigator requested the sanitation records that you reported were stored offsite. No such records were provided at any time during the inspection.
7. 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 cooked ready-to-eat crabmeat lists a monitoring procedure at the Cooking critical control point that is not adequate to control pathogen survival. FDA recommends continuously monitoring cook times and temperatures to ensure that the critical temperatures listed in your plan are maintained for the entire duration of the cook time.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.
As the owner, operator, or agent in charge of your facility you should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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 in violation of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] and the seafood HACCP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act [21 U.S.C. § 350d] and 21 CFR Part 1, Subpart H.
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), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). 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: Shari H. Shambaugh, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Shambaugh at (407) 475- 4730.
Emma R. Singleton
Director, Florida District