Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Dallas District Office|
4040 North Central Expressway
Dallas, Texas 75204
June 25, 2015
Leonard H. Youngren, Owner
Gladys’ Seafood, Inc.
996 F.M. 2001
Buda, TX 78610
Dear Mr. Youngren:
We inspected your seafood processing facility, located at 996 FM 2001, Buda, TX on April 1 through April 3, 2015. 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 pasteurized canned crabmeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 were 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 for pasteurized canned crabmeat lists a critical limit, “Refrigerated temperature less than or equal to (b)(4)F or as marked on product label”, at Receiving critical control point that is not adequate to control pathogen growth or toxin formation, including Clostridium botulinum. Specifically, this critical limit does not ensure the products were held at or below an ambient or internal temperature of 40°F throughout transit; or if the transit time was less than four hours, that the internal temperature of the product at the time of receipt was 40°F or less. This is a repeat observation from our letter dated January 22, 2014.
In addition, you have not established monitoring records for the Receiving critical control point. For example, your firm did not have records showing the truck temperatures or internal product temperatures of pasteurized canned crabmeat received on March 30, 2015.
Furthermore, your HACCP plan does not reflect your firm’s actual operations. You stated to our investigator you receive the pasteurized canned crabmeat on ice, and that you check the product for adequacy of ice. For your firm to utilize this control strategy at the Receiving critical control point, you must establish an appropriate critical limit and monitoring frequencies in your HACCP plan, and establish a recordkeeping system for this critical control point.
2. 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 and frequency of continuously monitoring the temperature of the cooler at the Storage critical control point to control pathogen growth or toxin formation, including Clostridium botulinum, listed in your HACCP plan for pasteurized canned crabmeat. Specifically, you did not monitor the temperature of the trailer where you occasionally stored pasteurized canned crabmeat. For example, you did not monitor the temperature of the pasteurized canned crabmeat after your cooler went out on July 14, 2014, through July 18, 2014.
In addition, you must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, a review of your storage monitoring records found you did not ensure the records contained the actual values obtained during monitoring. Specifically, your temperature charts do not include the time and date of the data they represent.
3. 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 pasteurized canned crabmeat at the Storage critical control point to control pathogen growth or toxin formation, including Clostridium botulinum, is not appropriate. Specifically, your corrective action plan does not address how you will determine the cause of the critical limit deviation. This is a repeat observation from our letter dated January 22, 2014.
4. You must sign and date the HACCP plan at least annually, and upon any modifications to the plan, to comply with 21 CFR 123.6(d). HACCP plans should be reevaluated to determine the adequacy of the plan at least annually. However, your firm has not reevaluated your current HACCP plan since June 11, 2013.
For more information on critical limits associated with pathogen growth as a result of temperature abuse, see Chapter 12 of the HACCP Guide. For more information on Clostridium botulinum toxin formation, see Chapter 13 of the HACCP Guide. The Fish and Fishery Products Hazards and Controls Guide, 4th Edition, is available at http://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 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 a revised HACCP plan and monitoring 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 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 U.S.C. 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.
Please send your reply to the Food and Drug Administration, Attention: Jamie M. Bumpas, Compliance Officer, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Jamie M. Bumpas at 214-253-5336.
Reynaldo R. Rodriguez, Jr.
Dallas District Director