Inspections, Compliance, Enforcement, and Criminal Investigations
Alby's Seafood, Inc. 10/15/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
October 15, 2012
UPS OVERNIGHT MAIL
Albert Anthony Godinich, Jr., President and Owner
Alby’s Seafood, Incorporated
3402 Hwy 35 North
Fulton, Texas 78358
Dear Mr. Godinich:
We inspected your seafood processing facility on June 6 – 12, 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 drum, flounder, and canned pasteurized crabmeatare adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay 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.
We received your response letter dated June 18, 2012, after a review of your response we find the following violations to exist.
Your significant violations were as follows:
1. 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b).
However, your firm does not have a HACCP plan for drum or flounder to control the food safety hazard of environmental chemical contaminants and pesticides. Your receiving checklist collected during the inspection documents the receipt drum and flounder during the month of June 2012.
2. 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 canned pasteurized crabmeat lists a critical limit of refrigerated temperature less than or equal to (b)(4)°F at receiving critical control point that is not adequate to control the food safety hazard of Clostridium botulinum.
Specifically, your firm picks up orders of canned pasteurized crabmeat at (b)(4) in your refrigerated truck. Your HACCP plan entitled “HACCP Plan for Pasteurized Crab Meat” revised on June 16, 2012, has your critical limit at receiving critical control point as refrigerated temperature less than or equal to (b)(4)°F upon receipt. During the inspection the investigator was told the canned pasteurized crabmeat is placed on ice prior to transporting from (b)(4) to Fulton, Texas.
The 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance in Chapter 13 states that critical limits for fish or fishery products delivered refrigerated (not frozen) may include: all lots received are accompanied by transportation records that show the product was held at or below 40°F throughout transit. For products delivered on ice, the product should be completely surrounded by ice at the time of delivery. If the product is delivered refrigerated with a transit time (including all time outside a controlled temperature environment) of four hours or less, the critical limit should ensure the time of transit did not exceed the four hours and internal temperature of the product 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, should be revised where appropriate once a modification to your critical limit is made.
3. 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 procedures and frequency noted in your HACCP plan for canned pasteurized crabmeat, to document taking cooler temperature (b)(4) at the storage critical control point to control Clostridium botulinum. Your HACCP plan states you will conduct a visual check (b)(4) and record your temperatures on the cooler temperature log. However, during the inspection on June 6 and 7, 2012, the investigator observed the cooler temperature at 48°F. There were no records available to demonstrate your firm had conducted the (b)(4) visual check of the cooler temperature on these days. In addition, your high temperature alarm did not indicate your cooler had exceeded your critical limit on these days.
4. 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 canned pasteurized crabmeat at the storage critical control point to control the food safety hazard of Clostridium botulinum is not adequate. Your HACCP plan revised on June 16, 2012, states to place the product on hold until an investigation can be performed to determine the total time and temperature the product exceeded its critical limit.
The 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance in Chapter 13, states you must identify actions that will be taken to regain control over the operation after a critical limit deviation.
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-Jonesat 214-253-5242.
Reynaldo Rodriguez Jr.
Dallas District Director