Inspections, Compliance, Enforcement, and Criminal Investigations
Mkg Provisions Inc 1/30/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
January 30, 2013
Mr. Richard Gil Tubb
Chief Executive Officer
Mkg Provisions Inc.
1177 NW 81st Street
Miami, FL 33150
Dear Mr. Tubb:
We inspected your seafood processing facility located at 1177 NW 81st Street, Miami, Florida 33150, from 12/11/2012 to 12/28/2012. 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 fish and fishery products, including but not limited to: cold smoked vacuum packed salmon, and your hot smoked vacuum packed smoked marlin 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:
- You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have 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 a HACCP plan for your hot-smoked vacuum packed marlin that your firm began processing on 11/02/2012, to control the food safety hazards of Pathogenic bacterial growth - temperature abuse, Clostridium botulinum toxin, allergens/additives and metal inclusion.
- 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption”. However your firm’s HACCP plan for cold-smoked vacuum packed salmon, entitled “***Ready to Eat Seafood Products” does not list the food safety hazards of allergens/additives and metal inclusion.
- 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 of, “***every batch continuously monitored with continuous temperature recording devices” at the “Brining” critical control point to control Clostridium botulinum toxin formation listed in your HACCP plan for your ready to eat cold-smoked, vacuum packed salmon entitled, “***Ready to Eat Seafood Products”. Specifically, there was a lack of “brine room” temperature records of smoking chambers for two out of three ovens used to process cold-smoked, ready to eat salmon identified as lots #1725 and #1726 on production records dated 12/10/2012, and 12/06/2012, respectively.
- You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the “Brining” critical control point to control Clostridium botulinum toxin formation in finished product listed in your HACCP plan for your ready to eat cold-smoked, vacuum packed salmon, entitled “***Ready to Eat Seafood Products” .
Specifically, you failed to implement the record keeping of “***Brine concentration or mixture” or, “***Weight of fish in brine or mixture” for cold-smoked, ready to eat salmon identified as lots #1725 and #1726 on production records dated 12/10/2012 and 12/06/2012.
- You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR Part 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard”. However, your firm’s HACCP plan for your cold-smoked vacuum packed salmon entitled, “Ready to Eat Seafood Products” lists critical limits “For each Preventive Measure” at the critical control point of “Brining” that is not adequate to control “Clostridium botulinum toxin formation in finished product”.
Your HACCP plan for cold-smoked, vacuum packed salmon, entitled “Ready to Eat Seafood Products” lists critical limits at the “Brining” critical control point as follows:
- “Proper brine concentration or mixture.”
- “***Weight of fish per standard volume of brine not to exceed 660#.”
- “***Proper time in brine or mixture.”
The critical limits do not specify a value or minimum/maximum parameters to be monitored to ensure control of the identified hazard of Clostridium botulinum toxin formation in the finished product.
- You must adequately monitor sanitation conditions and practices during processing to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, the prevention of cross-contamination from insanitary objects, the protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency to ensure control as evidenced by:
- Food contact equipment and surfaces were cleaned without a distinct wash step or the use of a detergent cleanser prior to sanitizing.
- Food residues were observed on the equipment after cleaning.
- An employee was observed using a pressurized water spray hose to clean the surface of the floor in the skinning area. Splash debris from the floor was observed landing on and coming into contact with exposed, ready to eat smoked salmon racks that were stored uncovered in the skinning area.
- There was condensate observed dripping from the ceiling surfaces in the finished product slicing area.
- Fish residues were observed on the blade and conveyor surfaces of automatic slicing machines.
- Fish residues were observed to be blowing from the automatic slicing machines onto previously cleaned processing tables in the packaging area of production.
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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover the FDA’s cost for certain activities, including re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. § 379j31(a)(2)(B)). FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
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: Ms. Carla Norris, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Ms. Norrisat 407-475-4730.
Emma R. Singleton
Director, Florida District