| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District Office|
4040 North Central Expressway
Dallas, Texas 75204-3128
November 20, 2015
Joseph G. Genitempo, Manager, Owner
Mark Genitempo, Owner
H & H Seafood
1440 Cedar Post Lane
Houston, TX 77055
Dear Messrs. Genitempo:
We inspected your seafood processing facility, located at 1440 Cedar Post, Houston, TX 77055 on June 3 – July 7, 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, ready-to-eat crabmeat, and tuna areadulterated, in that they have been prepared, packed, or held under insanitary conditions wherebythey 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 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 plans for pasteurized canned crabmeat, refrigerated ready-to-eat crabmeat, and scombroid (histamine) species do not list a critical limit at the storage critical control points to control pathogenic bacteria growth and toxin formation, Clostridium botulinum toxin formation, and scombrotoxin formation.
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 plans at the storage critical control points to control the identified food safety hazards are not appropriate.
Your corrective actions at the storage critical control points for your refrigerated, ready-to-eat crabmeat, pasteurized canned crabmeat and scombroid (histamine) species state “Dispose of product if temp. goes above limit for (b)(4) hours.” This corrective action does not include performing an evaluation of the total time and temperature exposure when a critical limit is exceeded. Your corrective action plan should include either an evaluation of the total time and temperature exposure or destruction of the product, regardless of the amount of time the temperature was above the critical limit.
3. You must implement the monitoring procedures and frequencies 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 frequencies at the storage critical control point. Your firm’s HACCP plans for pasteurized canned crabmeat, refrigerated, ready-to-eat crabmeat and scombroid (histamine) species state you are “monitoring of temp recorder in cooler” with a frequency of “(b)(4)” and a “visual check of monitoring device (b)(4).” However, you are not implementing this monitoring procedure and frequency. Specifically, you were unable to provide the cooler temperature monitoring records from October 16, 2014 through December 23, 2014.
Furthermore, you are not changing the cooler temperature-recording charts on your temperature-recording device every (b)(4) days, per the device manufacturer’s specifications. Without changing the temperature charts (b)(4), you are unable to ensure a deviation from a critical limit can be identified, in order to take appropriate corrective actions.
4. You must verify your HACCP plan is adequate to control the identified food safety hazards, and ensure the plans are effectively implemented, including calibration of process monitoring instruments and reviewing, signing, and dating critical control point monitoring records, to comply with 21 CFR 123.8(a)(2). Specifically, process-monitoring instruments must be calibrated, including thermometers and temperature-recording devices. However, your temperature-recording device used to monitor the temperature of your cooler has never been calibrated, which does not ensure the seafood products stored in your cooler are maintained at 40°F or less.
Additionally, your cooler temperature monitoring records for April 30, 2014 through October 15, 2014, and for December 14, 2014 through June 2, 2015, were not signed and dated, indicating no one at your firm has reviewed these records to ensure the temperature of your cooler was maintained at 40°F or below.
In addition, your HACCP plans must also identify, at a minimum, what you are monitoring at each critical control point, as well as provide for a recordkeeping system to document monitoring of the critical control points, as required by 21 CFR 123.6(c)(4) and 123.6(c)(7), respectively. However, your HACCP plan does not list what you will be monitoring at each critical control point, nor does your plan list any of the records you use to document the monitoring of the critical control points.
There is a significant history of violations at this facility, including prior issued advisory letters and a regulatory meeting held with Dallas District on April 14, 2014. 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.
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 an updated HACCP plan, critical control point monitoring records, calibration 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 he 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