Inspections, Compliance, Enforcement, and Criminal Investigations
Productos Marinos,C.A (Promarca) 9/12/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD|
September 12, 2011
Reference No. 209613
VIA EXPRESS MAIL
Mr. Alexander Sarria
Productos Marinos C.A.
Calle 51, Sector La Playa, Local No 22-30
San Francisco, El Bajo, Estado Zulia
Dear Mr. Alexander Sarria:
On March 22, 2011 through March 29, 2011, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at Calle 51, Sector La Playa, Local No 22-30, San Francisco, El Bajo, State of Zulia, Venezuela. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). The inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection listing the deviations found at your firm. We received your written responses to the FDA-483 on April 14, 2011 and May 4, 2011 via email. Our evaluation of the inspectional information coupled with our evaluation of your firm’s information submitted within your responses concludes that your corrective actions to date are not adequate to address the deviations noted during the inspection and that your revised HACCP plans continue to have problems.
In accordance with Title 21, Code of Federal Regulations, Section 123.6(g) [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 crabmeat products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
FDA has recently published a 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (i.e., the Hazard Guide). You may find the Act, the seafood HACCP regulation, and the Hazard Guide through links in FDA's home page at www.fda.gov.
The deficiencies in your compliance with the seafood HACCP regulation are 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). 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 provided in your May 4, 2011 response for “Pre Cooked Crab Meat Product” does not list the food safety hazard of pathogen growth and toxin formation, including Staphylococcus aureus growth and toxin, at the Receiving critical control point for the cooked crabmeat that you receive. Staphylococcus aureus produces a toxin which is heat stable and not eliminated through thermal processing.
Your firm receives previously cooked blue crab and further processes and packages the crabmeat in 1 lb plastic containers as a ready-to-eat food. This crabmeat originates from the gathering centers of Bobures and Puerto Concha, located at the South of the Lake of Maracaibo. Your firm should include controls in your HACCP plan which assures that the crabmeat is transported under safe conditions which prevent exposures to unsafe temperatures. Because transport times appear reasonably likely to (b)(4), FDA recommends monitoring the adequacy of ice surrounding the crabmeat at receipt AND measuring the internal temperatures from at least 12 randomly selected containers.
- 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 critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). 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." However, the following HACCP plans that your firm provided in your May 4th response do not address the following critical control points:
- The Pre-Cooked Crab Meat HACCP plan, which you are using for both crabs that you receive pre-cooked and for crabs that you cook, does not list the critical control point of:
- In-Process Refrigerated Storage for cooked crab to control pathogen growth and toxin formation.
After your cooking process of raw crabs, your firm is immediately cooling cooked crabs with fans (b)(4) to cool the cooked crabs to room temperature and then placing them in a cooler maintained at (b)(4) for further cooling before processing the cooled crabs the following day. FDA recommends that cooked seafood be cooled from 140 °F to 70 °F within 2 hours, followed by cooling from 70 °F to 40 °F within an additional 4 hours to control pathogen growth.
- Picking and Packing process to control pathogen growth and toxin formation.
This step in your processing of previously cooked crab has multiple steps which can cause the process to take a considerable amount of time. If the ambient temperature of the room is not controlled, the product should either remain iced during the process and the ice monitored every 2 hours or the process should be limited to 2 hours to control pathogen growth and toxin formation.
- The “Pasteurized Crab Meat” HACCP plan does not list the critical control point of:
- In-Process Refrigerated Storage for crab meat in hermetically double-seam sealed metal cans for controlling the food safety hazard of pathogen growth and potential toxin formation.
Your “Pasteurized Crab Meat” HACCP plan (i.e., provided in your response and dated January 2011) has a single critical control point for “Refrigeration Storage” following the critical control point of “Pasteurization”. However, our inspection revealed that there is a refrigerated storage step for the in-process product where the hermetically sealed crabmeat is stored overnight in your firm’s cooler. Pathogen growth and potential toxin formation, specifically Clostridium botulinum and Staphylococcus aureus toxin formation are reasonably likely hazards which can occur as a result of time and temperature abuse during this in-process storage period. Staphylococcus aureus toxin is heat stable, and heat treatment, including pasteurization, may not be adequate to eliminate or denature the toxin once it is formed.
- Monitoring the integrity of the cans to control the identified hazard of Clostridium botulinum and bacterial pathogens through a visual examination of containers and a destructive examination.
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for:
- “Pre Cooked Crab Meat Product” HACCP plan provided in your May 4th response does not list adequate corrective actions at the Cooking and Storage critical control points. Your corrective action is to evaluate the product based on time and temperature; however, the action does not specify the method of evaluation or the criteria. Further, your plan does not state what action you will take to prevent adulterated product from being distributed or how the cause of the deficiency will be corrected.
- “Pasteurized Crab Meat” HACCP plan provided in your May 4th response does not list corrective actions at the:
- Pasteurization Hot Bath and Cold Bath critical control point that are adequate to control the hazard posed by Clostridium botulinum growth and toxin formation. Your corrective action is to evaluate the product or the storage; however, the corrective action does not specify the method of evaluation or the criteria. Your plan does not state what action you will take to prevent adulterated product (e.g. destroy product) from being distributed or how the cause of the deficiency will be corrected;
- Refrigeration Storage critical control point that are adequate to control the hazard posed by Clostridium botulinum growth and toxin formation. Your corrective action is to evaluate the storage room; however, you do not state that you will be evaluating on the time and temperature exposures, or what action you will take on the product determined to be potentially unsafe.
- You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm’s HACCP plan provided with your May 4th response, for:
A. “Pre Cooked Crab Meat Product” lists a monitoring procedure:
- At the Cooking critical control point that is not adequate to control biological pathogens. Specifically, your firm uses the wall clock to measure time, and a thermometer and pressure gauge on the cooking apparatus to measure temperature and pressure respectively. FDA recommends a continuous monitoring of time, temperature, and pressure recording devices to record these cook parameters with a review of the recorded data for each cycle.
- At the Refrigeration Storage critical control point that is not adequate to control pathogens. FDA recommends that your firm monitor temperatures with a continuous temperature recording device and review those records daily to assure your critical limits have not been exceeded.
B. “Pasteurized Crab Meat” lists a monitoring procedure:
- At the Cooking critical control point that is not adequate to control Clostridium botulinum. Specifically, your firm uses the wall clock to measure time. FDA recommends a continuous monitoring of time and temperature with a recording device to record cook parameters, with a review of the recorded data for each cycle. Based on our investigator’s observations, you currently use a data logger to continuously monitor your pasteurization process. This should be reflected in your plan.
- At the Refrigeration Storage critical control point that is not adequate to control Clostridium botulinum. Your firm should monitor temperatures with a continuous temperature recording device and review those records daily to assure your critical limits have not been exceeded.
- 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 provided in your May 4th response for:
A. “Pasteurized Crab Meat” does not list the critical limits of the maximum load for the process, the type of crabmeat, and initial temperature of the cans or product at the (b)(4) critical control point to control Clostridium botulinum;
B. Cooked, Unpasteurized Crabmeat (i.e., Fresh) does not list a critical limit of the maximum load of the process at the “Cooking” critical control point to control pathogens.
Your firm appears to have modified your HACCP plan for Pasteurized Crab Meat at the (b)(4) critical control point by increasing the critical limit from (b)(4). However, there is no information specifying which temperature is being monitored (i.e., product temperature, temperature of the heating media, temperature of the cooking apparatus, etc.). FDA currently recommends maintaining an “internal” product temperature of 85°C (185 °F) for a minimum of 31 minutes. This temperature should address exposure of the largest container, at the coldest spot in the container, located at the coldest spot in the cooker. Please provide information for your target internal temperatures and dwell times.
For additional information and guidance concerning the hazards of pathogen growth, Clostridium botulinum growth and toxin formation, and pathogen survival through cooking, please refer to chapters 12, 13, and 16 of 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.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.html
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulations (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: Stuart A. Feldman, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Mr. Feldman by phone at (240) 402-3006 or via email at email@example.com
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition