Martin Preferred Foods, L.P. 11/15/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
November 15, 2012
UPS OVERNIGHT MAIL
Michael Tapick, Chief Executive Officer and President
Martin Preferred Foods, LP
2011 Silver Street
Houston, Texas 77007
Dear Mr. Tapick:
We inspected your seafood processing facility, located at 1404 E. Houston Street, San Antonio, Texas 78202 on June 14 – June 20, 2012 and October 11 – 15, 2012.
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 (21 CFR 123). 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 mahi-mahi, amberjack and ready-to-eat crabmeat are adulterated, in that they have been prepared, packed, or held under insanitary conditions where by 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
Your significant violations are as follows:
1. 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 entitled “HACCP plan for Scombrotoxin Species, Fresh Crabmeat & Shucked Oysters, Pasteurized Crabmeat & Caviar in Metal Cans and Vacuum Packaged Smoked Fish” dated December 6, 2011, list a critical limit that states to take a representative sample of all incoming products ensuring the temperature will be ≤ 40F at receiving at your San Antonio facility. This receiving critical limit is not adequate to control histamine formation in scombrotoxin species or pathogen growth and toxin formation in ready-to-eat seafood. Our inspection documented the receipt of fresh amberjack, mahi mahi and ready-to-eat crabmeat products.
The 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance in Chapter 7, states a critical limit for fish or fishery products delivered refrigerated (not frozen) as: all lots received are accompanied by transportation records that show the product was held at 40°F throughout transit. For fish delivered under ice you should ensure the fish are completely surrounded by ice at the time of delivery. In addition, for fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less, you should ensure the documented transit time does not exceed 4 hours and the internal temperature of the fish at the time of delivery does not exceed 40°F.
Also, due to the inadequate critical limit, your monitoring, record-keeping, verification procedures, and corrective action plan, may need revision where appropriate once modifications to your critical limit are made.
2. 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 noted in your HACCP plan entitled “HACCP plan for Scombrotoxin Species, Fresh Crabmeat & Shucked Oysters, Pasteurized Crabmeat & Caviar in Metal Cans and Vacuum Packaged Smoked Fish”, at the receiving and storage critical control points to control pathogen growth and toxin formation are inadequate.
a) Your corrective action plan at receiving, states “If product temperature exceeds 40°F, product will be segregated and returned to (b)(4) as necessary”. It does not address that the cause of the deviation is corrected.
b) Your corrective action plan at the storage critical control point involving a critical limit deviation states “at (b)(4), get unit back to compliance and check product temperature with (b)(4) thermometer.”
The 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance in Chapter 12, states you must take one of the following corrective actions to a product involved in a critical limit deviation: Chill and hold the affect product until an evaluation of the total time and temperature exposure is performed. A product with cumulative exposures that exceed the critical limits recommended should be cooked or diverted to a use in which the critical limit is not applicable, after giving consideration to the fact that any S. aureus or B cereus toxin that may be present may not be inactivated by heat; or destroy the product; or diverted to a non-food use.
3. 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, your firm’s HACCP plan entitled “HACCP plan for Scombrotoxin Species, Fresh Crabmeat & Shucked Oysters, Pasteurized Crabmeat & Caviar in Metal Cans and Vacuum Packaged Smoked Fish” does not list the critical control point of receiving returned fish or fishery products at your San Antonio facility from your customers prior to returning the products to your (b)(4) facility. Because your firm receives returned product from your customers, you must have a receiving critical control point to control the food safety hazards of the returned product(s) upon receipt at your facility.
In addition, we noticed you have fish and fishery products with different safety hazards listed on the same HACCP plan. In accordance with 21 CFR 123.6(b)(2), your HACCP may group the same kind fish and fishery products together or group production methods together if the same safety hazards, critical control points critical limits and procedures required are identical. However, your HACCP plan entitled “HACCP plan for Scombrotoxin Species, Fresh Crabmeat & Shucked Oysters, Pasteurized Crabmeat & Caviar in Metal Cans and Vacuum Packaged Smoked Fish” list fish or fishery products that have different safety hazards and should be covered by a separate HACCP plan according to its known hazard, for example: scombroxtoxin species have a histamine hazard; pasteurized crabmeat, caviar in metal cans and vacuum packaged smoked fish have a Clostridium botulinum hazard; and fresh crabmeat has a pathogen growth and toxin formation hazard.
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 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). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)).
FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Ronda Loyd-Jones, Compliance at 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have questions regarding any issues in this letter, please contact: Ronda Loyd-Jones at 214-253-5242.
Reynaldo R. Rodriguez Jr.
Dallas District Director