Inspections, Compliance, Enforcement, and Criminal Investigations
Bartush-Schnitzius Foods Co. 10-Nov-05
Department of Health and Human Services
Public Health Service
November 10, 2005
RETURN RECEIPT REQUESTED
Mr. John A. Rubi, President
Bartush-Schnitzius Foods Co.
1137 North Kealy Street
Lewisvilte, Texas 75057
We inspected your seafood processing facility, located at 1137 North Kealy Street, Lewisville, Texas on September 8-13, 2005. 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, and the Current Good Manufactuong Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123& 110). 1n 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, yaus surimi (vacuum packaged imitation crabmeat and salmon) and seafood salads and dips are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby 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 finks in FDA's home page at www.fda.gov. Your significant violations were as follows :
1. You must take corrective action when a deviation from a critical limit occurs, to comply with 21 CFR §123.7(a). However, your firm did not take a corrective action to control the hazard of pathogen growth and toxin formation, including Clostridium botulinum when your storage cooler deviated from the critical limit (CL) listed in your HACCP plans for surimi (i.e., vacuum packaged imitation crabmeat and salmon) and blended ready-to-eat seafood products at the storage critical control point (CCP).
Computerized temperature recordings dated 12/27-28/05 recorded refrigeration temperatures that constantly spiked above the CL of 41 degrees Fahrenheit.
These same computerized temperature recordings dated 1/10-12/05 recorded storage cooler temperatures that exceeded 41 degrees Fahrenheit for four hours or more each day.
Your firm's computerized temperature recording records did not have any temperatures recorded from 3:00 p.m. on 7/14/05 until 7/19/05 at 6:00 a.m. The records for those datesitimes are blank.
According to management, during all the temperature excursions, pasteurized vacuum packed surimi (imitation crabmeat and salmon) and finished seafood salads and dips were stored in the storage cooler. Your firm did not take or document any temperatures during any of the temperature excursions or implement the corrective actions as listed in your plans for your suritni (vacuum packaged imitation crabmeat and salmon} and blended ready-to-eat seafood products.
Because you chose to include corrective action plans in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR Part 123.7(b). However, your corrective action plans for surimi (i.e., vacuum packaged imitation crabmeat and salmon) and blended ready-to-eat seafood products at the cooler storage critical control points are not adequate because they do not include correcting the source of the problem that caused the CL deviation (i.e., to regain control of the operation after the CL deviation). For example, you could list that you will make repairs or adjustments to the cooler following temperature excursions above the CL or that you will move product to another cooler facility.
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 CPR 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.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Carolyn A. Pinney at 214-253-5220.
Michael A. Chappell
Dallas District Director