Inspections, Compliance, Enforcement, and Criminal Investigations
Gadaleto's Seafood Market, Inc. 7/28/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
July 28, 2009
WARNING LETTER NYK 2009-14
RETURN RECEIPT REOUESTED
Steven J. Kraus, General Manager
Gadaleto's Seafood Market, Inc.
246 Main Street
New Paltz, NY 12561
Dear Mr. Kraus:
We inspected your seafood processing facility, located at 246 Main Street, New Paltz, NY, on Apri1 28 and 30,2009. We collected Samples 531069 and 531070 during this inspection. 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 regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 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 USC Section 342(a)(4). Accordingly, your refrigerated ready-to-eat pasteurized crabmeat and refrigerated ready-to-eat vacuum packaged cold smoked salmon products 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 and Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for ready-to-eat pasteurized crabmeat in hermetically sealed containers and vacuum packaged ready-to-eat cold smoked salmon does not list adequate monitoring procedures/frequencies at the "Storage" critical control point to control pathogen growth. Specifically, your monitoring procedures list that you will check and document product temperature in display case and in walk-in cooler twice daily during business hours. This monitoring procedure/frequency is not adequate to ensure that temperature fluctuations exceeding your temperature critical limit have not occurred for extended time periods between the twice daily checks and between business hours such as during weekends and holiday. FDA recommends the use of a continuous temperature monitoring and recording device in order for your firm to have the capability to assess any temperature deviations that may occur during any 24 hour period.
2. You must implement the monitoring procedures and recordkeeping system that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not monitor and record the critical limits at the "Receiving" critical control point as listed in your HACCP plan for "ready-to eat pasteurized crabmeat in hermetically sealed containers and vacuum packaged ready-to-eat cold smoked salmon". Specifically, your firm received ready-to-eat pasteurized crabmeat in hermetically sealed containers on 4/20/09 and 4/23/09 and vacuum packaged ready-to-eat cold smoked salmon on 4120/09 and you do not have any documentation that these shipments were adequately monitored upon receipt. Also, on your "Smoked Fish and Pasteurized Products Receiving Log" you recorded that ready-to-eat pasteurized crabmeat in hermetically sealed containers were received packed on ice on 1/8/09,1/22/09,2/5/09,2/12/09,2/19/09,2/26/09, 3/5/09, 3/19/09, 3/26/09, 4/2/09, 4/14/09, and 4/16/09 when in fact this product is not received on ice and is only received in cardboard cases on a refrigerated truck with no ice or gel packs and no temperature monitoring as stated by management.
FDA recommends monitoring receiving records showing the results of the adequate time/temperature for the duration of the transit period to your facility, with a continuous monitoring record at receiving.
3. 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 safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 2I CFR Part 110 as evidenced by:
Specifically, you do not have sanitation monitoring records for April 2009, and the following sanitation conditions and practices were observed during processing on 4/28/09:
Safety of Water: a) Visible build-up of product residue and a green substance inside spray nozzle head on top of the pressure water hose stored on the primary processing/cutting table and used to rinse off fish after cutting and before packaging; and b) Apparent black mold-like substance inside ice machine used to make and store ice that is used to cover fish in the walk-in cooler.
Condition and Cleanliness of Food Contact Surfaces: a) Visible build-up of product residue on four production knives after cleaning and before use that were stored in a plastic knife holder located on the side of the primary fish processing/cutting sink, b) Visible build-up of product residue and debris was observed inside plastic knife holder located on the side of the primary fish processing/cutting sink where clean knives were being stored, and c) Visible build-up of product residue and debris was observed inside plastic knife holder located on next to the hand washing sink in the primary fish processing/cutting area where clean knives were being stored.
Prevention from Adulteration: a) condensation drip was observed to be dripping off the condenser fan unit on the ceiling in the walk-in cooler directly onto exposed swordfish that was being stored on ice in the walk-in cooler, b) condensation drip was observed to be dripping off the rusted metal racks in the walk-in cooler directly onto exposed fish in several areas of the walk-in cooler, c) Heavy buildup of dried fish scales and fish debris observed on the wall directly above and below the primary processing/cutting sink, and d) Exposed glass light shield observed directly above the stainless steel product staging table near the utensil/equipment washing sink.
Maintenance of Hand Washing: a) The hot water handle to the hand washing sink in the primary fish processing/cutting area was observed to have a heavy build-up of old product residue allowing for the recontamination of hands after washing them.
Exclusion of Pests: a) Approximate 1/2" gap above the exit door next to the walk-in cooler leading directly outside and allowing for the entry of pests into the facility.
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 plan 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: Patricia A. Clark, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo, NY 14202. If you have questions regarding any issues in this letter, please contact Patricia A. Clark at 716-551-4461, ext. 3168.
Otto D. Vitillo
New York District