Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fish-busterz-llc-08222014
Timestamp: 2020-08-11 14:16:26
Document Index: 288422615

Matched Legal Cases: ['art 123', 'art 110', 'art 123', '§ 342', '§ 379', '§ 379', 'art 123', 'art 110', 'art 1']

Fish Busterz, L.L.C. - 08/22/2014 | FDA
Fish Busterz, L.L.C. - 08/22/2014
Fish Busterz, L.L.C. August 22, 2014
FLA-14-23
Charles H. Renier, Manager/Owner
Fish Busterz L.L.C.
Cc: Colleen Quirk, Manager/Owner
Cc: Eric Dickstein, Manager/Owner
Dear Mr. Renier:
We inspected your seafood processing facility, located at 6565 4th Avenue, Stock Island, FL 33040 on April 29-30, 2014. 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 regulations 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 fresh King Mackerel, raw and gutted with head on, is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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.
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” Your firm’s HACCP plan for King Mackerel does not list the food safety hazard(s) of Ciguatera Fish Poisoning (CFP) and allergen.
Your written response, dated August 14, 2014, listed CFP and Allergen in your firm’s updated Hazard Analysis, however you failed to provide an updated HACCP plan to support that it has been incorporated into your HACCP plan.
2. 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 123.3 (c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.”
Your firm’s HACCP plan(s) for King Mackerel lists a critical limit(s), “completely surrounded by ice”, “the product is not out of refrigeration for more than 4 hours cumulatively”, “all lots received are accompanied by harvest vessel records”, and “the fish were stored completely and continuously surrounded by ice after (sic.) within the time limits listed” at the receiving, storage, and processing critical control point(s) that is not adequate to control Scombrotoxin (Histamine) Formation, for a primary processor such as yourself, receiving fish directly from the harvest vessels.
Your employee identified for our investigator your secondary processor HACCP plan as the plan most applicable to your operations. We contend that you are a primary processor and not a secondary processor. Your HACCP plan currently lists controls at the receiving CCP as a secondary processor. There were no monitoring records available for review during the inspection to support any monitoring activities as a primary processor.
As a primary processor, in addition to checking the internal temperature of the fish and performing a sensory examination, FDA recommends one of two options for controlling scombrotoxin hazard at receiving: (1) harvest vessel records or (2) histamine testing on every batch received of a representative sample of fish that shows less than 50 ppm of histamine in all fish in the sample. There were no monitoring records available for review during the inspection.
This is a repeat observation from Form FDA 483 (FDA 483) Observation 2, dated January 25, 2011.
You were previously warned about this in Warning Letter FLA-07-20, dated August 29, 2007 and in an untitled letter, dated April 21, 2005.
3. 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 of every shipment by visually checking that ice completely surrounds fish upon receipt from the harvest vessel and recording the results on the receiving log at the receiving critical control point to control for Scombrotoxin (Histamine) Formation listed in your HACCP plan for King Mackerel. You also did not follow the monitoring procedures twice daily by visually checking that ice surrounds the fish and recording the results on the temperature log at the storage critical control point to control for Scombrotoxin (Histamine) Formation listed in your HACCP plan for King Mackerel at receipt of every shipment and at the receiving and storage critical control points to control for histamine formation, due to time/temperature abuse. Specifically,
a) Your employee stated that in practice, at time of receipt, the fish are unloaded, weighed, and placed in ice without a check or recording of the harvest vessel’s ice conditions and further stated that if the fish does not look good he will not accept it. Additionally, in your written response you did not provide any documentation that you perform internal temperature testing of the fish upon receipt or during storage. Your firm did not have monitoring records available for our investigators’ review during the inspection to demonstrate the performance of any monitoring activities as a primary processor
b) Your employee stated that in practice, he does not check the ice levels of fish during storage because it would be difficult since he would need to remove all the boxes and totes from the container to check the ones in the back. Additionally, in your written response you did not provide any documentation that you perform internal temperature testing of the fish upon receipt or during storage. Your firm did not have monitoring records available for our review during the inspection.
This is a repeat observation from Form FDA 483 (FDA 483) Observation 1, dated January 25, 2011.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s cost for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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. § 379j-31(a)(2)(B)]. For a domestic facility, FDA may assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
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 evaluation of 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 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: Randall L. Morris, Compliance Officer at 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Randall L. Morris, Compliance Officer at (407) 475-4741.