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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cracovia Co 10/18/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone (973) 331-4900
 

October 18, 2011
 

WARNING LETTER

UNITED PARCEL SERVICE
 

Mr. Christopher Zawisny, President
Cracovia Co.
2365 E. Linden Avenue
Linden, NJ 07036
 

12-NWJ-02
 

Dear Mr. Zawisny:

The Food and Drug Administration inspected your seafood processing facility, located at 2365 E. Linden Avenue, Linden, NJ from 06/15/2011 through 06/24/2011. We have found 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 &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 operates 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 refrigerated seafood products, such as, but not limited to: vacuum packed smoked mackerel, herring fillets in wine marinade, vacuum packed smoked salmon, vacuum packed smoked white fish, and vacuum packed smoked trout 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.

Please be advised that FDA has recently published a 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (i.e., the Hazard Guide). We have made references to the 4th Edition in our comments below.

Your 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 procedure of: 

• "Checking for temperature on delivery vehicle" at the receiving critical control point (CCP), to control Clostridium botulinum in your HACCP plan for seafood in wine marinade and "Ambient temperature during transportation" at the receiving critical control point (CCP) to control Clostridium botulinum,- Toxin Formation, (listeria), Pathogen Growth, Histamine formation listed in your HACCP plan for refrigerated vacuum packed seafood. You stated that incoming shipments are not checked for temperatures via thermometer, and there were no temperature receiving records to review. 

• Checking the temperature of the refrigerated storage units to control Clostridium botulinum in your HACCP plans for seafood in wine marinade and Clostridium botulinum, Toxin Formation, (listeria), Pathogen Growth, and Histamine formation listed in your HACCP plan for refrigerated vacuum packed seafood. Specifically, temperatures are typically not being taken on weekends, and you failed to document temperatures of the storage refrigerator on 05/04/11, 05/05/11, 05/7-9/11, 5/11/11, 05/14-17/2011, and 05119-6/8/2011. In addition, on 5/19/2011, no cooler temperatures were recorded when 60 cases of eviscerated smoked mackerel, 25 cases of smoked mackerel fillets, 15 cases of smoked eviscerated rainbow trout, 10 cases of smoked salmon fillet, and 5 cases of smoked rainbow trout fillets were delivered to your firm.
 

2. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for Seafood products in wine marinade lists a monitoring procedure at the:
 

• Receiving critical control point that is not adequate to control Clostridium Botulinum. Specifically, your HACCP plan states you will check the temperature on the delivery vehicle and compare with the Bill of Landing, on which you state the carrier checks a box stating temperature requirements are below 36°F or 0°F. Taking a one time temperature at receipt is adequate only when transit times are short, for example under 4 hours. Your firm receives herring fillets in wine marinade by truck from Woodstock Ontarion, Canada, which exceeds 4 hours in travel time. Performing a check of the temperature of the delivery vehicle and comparison with the Bill of Landing does not indicate the time and temperature of the delivery vehicle the entire time of transport to your facility which at times can exceed 4 hours. FDA recommends the delivery vehicle be equipped with a continuous monitoring time/temperature recording device.

• Refrigerated Storage critical control point that is not adequate to control Clostridium Botulinum. Specifically, your HACCP plan states you will "check temperature refrigerated storage units" visually, however your refrigerated units are monitored by a digital thermometer. FDA recommends the use of a continuous monitoring device capable of continuously monitoring and recording temperatures, such as a continuous temperature data logger for monitoring refrigerated cooler storage with a visual check of the recorded data once per day.
 

3. 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." However, your firm's HACCP plan for seafood products in wine marinade does not list the food safety hazard of Scombrotoxin (histamine) formation. 

4. 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 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 vacuum packed refrigerated smoked seafood products:
 

• Lists a critical limit, "Temperature Control of Incoming Shipment. Product can't exceed of 40°F for more of 8 hours during entire transportation, otherwise reject shipment", at the Receiving critical control point that is not adequate to control C. botulinum, Toxin Formation, (listeria) Pathogen Growth, and Histamine. Your critical limit permits refrigerated vacuum packaged seafood products to be stored during transportation above 40°F for up to 8 hours before your critical limit is exceeded. In addition, no upper temperature limit is included in your critical limit. During this elevated temperature, pathogens, toxin formation, and histamine may reach unsafe levels in your products. Moreover, because your firm is currently taking a one time temperature of the products at receipt, you will be unable to implement any strategy at receiving that is based on both time and temperature assessments. FDA recommends that refrigerated vacuum packaged seafood products be held continuously maintained at a temperature maximum of 40°F. 

• Lists a critical limit, "Temperature should not exceed of 40°F for more of 8 hours during holding and storage", at the Refrigerated Storage critical control point that is not adequate to control C. botulinum, Toxin Formation, (listeria) Pathogen Growth, and Histamine. Your critical limit is permitting refrigerated vacuum packaged seafood products to be stored above 40°F for up to 8 hours before your critical limit is exceeded. In addition, no upper temperature limit is included in your critical limit. During this elevated temperature, pathogens, toxin formation, and histamine may reach unsafe levels in your products. FDA recommends that refrigerated vacuum packaged seafood products be stored at a
temperature maximum of 40°F.
 

For additional information and guidance please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

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 you firm from operating.

Please 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 11 0). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to U.S. Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, NJ 07054, Attn: Stephanie Durso, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Ms. Durso at 1-973-331-4911.
 

Sincerely,

/S/
Diana Amador-Tore
District Director
New Jersey District