- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Reference #:
- Food & Beverages
Recipient NameMr. Tommy Forte
- Pescaderia Catano
Avenida Nereida, Edificio B Villa Pesquera
Cataño, PR 00962
- Issuing Office:
- Center for Food Safety and Applied Nutrition
466 Avenida Fernández Juncos
San Juan 00901-3223
- (787) 729-8500
Dear Mr. Forte:
The United States Food and Drug Administration (FDA) inspected your seafood processing and distribution facility located at Avenida Nereida, Edificio B Villa Pesquera in Cataño, PR 00962 on November 3-30, 2018 (dates not all inclusive). Our inspection found you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a seafood processor 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 seafood products are adulterated because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA regulations in the CFR through links in FDA's website at www.fda.gov.
During our inspection of your facility, our Investigator’s observations were noted on a Form FDA 483, Inspectional Observations, issued to you on November 30, 2018. As of the date of this letter, we have not received your firm’s written notification specifying the corrective actions implemented.
Your significant violations were as follows:
- 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).
Your firm processes fresh fish, such as Snapper, Tuna, Mahi-Mahi, Snook, Grouper, etc., mollusks, such as Conch, and crustaceans, such as Lobster and stone crab, for sale and distribution. You have not conducted a hazard analysis, in each type of fish or fishery product, to determine the potential species related hazards and process-related hazards that are reasonably likely to occur and their potential effect of the safety of the product.
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.” A food safety hazard that is reasonably likely to occur is one for which a prudent processor would establish controls because experience, illness data, scientific reports or other information provide a basis to conclude that there is reasonable probability that it will occur in the particular type of fish or fishery product being processed in the absence of those controls. Examples include Ciguatera Fish Poisoning and Scombroid Toxin (Histamine formation).
The 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
- Every processor shall have and implement a HACCP plan. Once you have conducted a hazard analysis for your seafood products, you must have and implement a written HACCP plan to control those identified hazards that are reasonably likely to occur and have a HACCP plan that at a minimum, lists the appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure the food safety hazards are controlled and comply with 21 CFR 123.6(a) and (c)(2).
You do not have written HACCP plans, for Snapper, Jack, Mackerel Pike, Grouper, Tuna, Mahi-Mahi, Hind, Queen Triggerfish, Conch, among others, to mitigate potential hazards at points of receiving, storage, processing, and distribution. Further, you do not monitor or have records to show that the products you receive were not temperature abused during transit/storage.
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.”
- You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing/sanitizing and toilet facilities, protection of food and food packaging material, exclusion of pests, among others. You do not have a sanitation monitoring program that addresses sanitation conditions and practices before, during, and after processing as required per 21 CFR 123.11(b). The following conditions and practices were observed on November 02 and 07, 2018:
a) Safety of water:
- The sink drain pipe located in the processing room is not connected to a sanitary drainage system and the hose used for cleaning is not equipped with a backflow prevention device.
b) Condition and cleanliness of food contact surfaces:
- Dirt and rust was observed on the mechanical slicing machine.
- Corrosion, dirt, and grime was observed on exterior and interior surfaces of the freezer units used to store fish and seafood.
c) Prevention of cross contamination:
- Two whole fish segregated for disposal were observed stored in a plastic bucket in the walk-in cooler, next to empty baskets used to place fresh fish in ice.
d) Maintenance of hand-washing, hand-sanitizing, and toilet facilities:
- The hand wash station located in the processing room was not equipped with hot water and the paper towel dispenser was empty. The station did not have written instructions showing how employees must wash their hands and they were entering the processing room without washing their hands.
- Visitors were also observed entering the processing room without washing hands and without hair protection.
e) Protection of food, food packaging material, and food contact surfaces:
- Condensation from the cooling unit of the walk-in cooler was observed dripping over the lid of a partially closed bin that held fish on ice. There was dust and dirt accumulation on the rear panel of the cooling unit.
- Two cans of insecticide spray were observed stored inside a red plastic basket located in a storage shelf cart in the processing room. Next to the basket was an unidentified glass bottle containing a yellow liquid, which was identified as shark oil. On the same shelf, there was also an unidentified plastic gallon bottle with a clear liquid, which was identified as vinegar.
f) Control of employee health conditions:
g) Exclusion of pests from the food plant:
- Approximately five  live cockroaches were observed on the wall in front of the processing room table.
- Several flies were observed flying in the processing room, the walk-in cooler, and the exterior premises.
- Four big plastic bins used to carry fish in ice were observed on the outside premises together with garbage and unused equipment. The observed unsanitary conditions create a harborage risk for insects and pests. Stagnant water, dirt, and tools such as shovels were observed in the bins’ interior.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the seafood HACCP and sanitation regulations (21 CFR 123), and other applicable laws. You should take prompt action to correct the violations noted in this letter. You are responsible for preventing further violations of the Act and all applicable regulations. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
Section 743 of the Act, [21 USC 379j-31], authorizes FDA to assess and collect fees to cover FDA’s costs 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 USC 379j-31(a)(2)(B)]. For a domestic facility, 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response documentation such as HACCP Plans for each type of fish (e.g., Histamine formers and Ciguatera species) you process and a Sanitation Plan 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.
Please send your reply to the Food and Drug Administration, Attention: Ramon Hernandez, District Director, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901. If you have questions regarding this letter, please contact Ms. Laura Kennedy, Compliance Officer, at (813) 915-7948, or via e-mail at: Laura.Kennedy@fda.hhs.gov.
Ramon A. Hernandez
Director, San Juan District Office and
Program Division Director,
Office of Human and Animal Food
Operations, Division IV East