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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Topway Enterprises, Inc. 14-Dec-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145

December 14, 2005




Mr. Jeff Liao, President
Topway Enterprises, Inc.
11810 Bellaire Boulevard
Houston, Texas 77076

Dear Mr. Liao:

We inspected your seafood processing facility, Topway Enterprises, Inc, located at 11810 Bellaire Boulevard, Houston, Texas on November 16 and 22, 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 Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 123 & 110). In accordance with 21 CFR § 123.6(g), failure of a processor of fish and fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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 tuna, farm-raised salmon, vacuum packaged yellowtail, farm-raised striped bass, and fresh flounder 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 links in FDA's home page at www.fda.gov.

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 to control the food safety hazards of parasites in fresh wild-caught flounder and chemical and drug hazards associated with farnn-raised striped bass.

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 listed in your HACCP plan for the critical control point (CCP) of receiving for fresh tuna, salmon, and vacuum packaged yellowtail to control histamine forming bacteria, pathogen growth, and toxin formation of Clostridium botulinum. Specifically, your firm's HACCP plan for fresh tuna lists a critical limit at the CCP of receiving that requires monitoring the internal temperature and/or adequate ice of the tuna; however, your firm has not documented any receiving temperatures for these fish products listed above since 5J1112t7fl4. Instead, your firm only records the weight of the tuna and salmon that is received. Therefore, the food safety hazards of histamine forming bacteria, pathogen growth, and toxin formation of Clostridium botulinurn are not controlled.

In addition, your firm has not implemented the monitoring procedure for the CCP for packaging fresh tuna because your firm does not record any temperatures for the processing room. During the inspection, the investigator recorded the temperature of 52° Fahrenheit (F) for the processing room ; however, your firm's HACCP plan for tuna lists a critical limit of [redacted] degrees F or not to exceed [redacted] degrees F for more than [redacted] hours. Therefore, the food safety hazard of histamine forming bacteria is not controlled.

3. 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, your firm did not record monitoring observations at the receiving and storage critical control points to control histamine formation, pathogen growth, and toxin formation by Clostridium botulinum. Specifically, your firm did not record any receiving temperatures or adequacy of ice for fish and fishery products since 5/11/2004. Furthermore, your firm discontinued recording the daily temperatures on 9/13/2005 for the temperature monitoring of the coolers and freezers where fish and fishery products are stored.

4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR § 123.11(b). However, your firm demonstrated to the investigator during the current inspection that you are not monitoring and maintaining sanitation conditions as they relate to seafood HACCP and ensuring conformance to 21 CFR Part 110. The following conditions were observed during the inspection.

Safety of Water that Comes in Contact with Food [21 CFR § 123.11 (b)(1)]:

  • Fish debris from previous processed fish was found in the lce machine and on the door to the storage area of the ice machine.

Condition and Cleanliness of Food Contact Surfaces [21 CFR § 123.11 (b)(2)]:

  • Fish processing tables contained cutting boards that were not property cleaned prior to processing tuna and salmon and had scored surfaces preventing adequate cleaning and sanitation.

  • Fish debris from previous operations was found on the dispenser for cellophane used to wrap tuna loins. The dispenser was not properly washed, rinsed, or sanitized prior
    to processing fresh tuna and salmon.

  • A plastic tub used for the storage of the fish processing utensils was observed to have a buildup of fish debris from previous processing.

  • Knives, hacksaw, and scaler used for processing fish were not property washed, rinsed, and sanitized.

  • Metal trays and plastic tubs, used in processing fish, contained fish debris from previous processing operations. These items were not washed, rinsed, or sanitized adequately.

Prevention of Cross-Contamination from Insanitary Objects [21CFR 123.11 (b)(3)]:

  • Employees working in the fish processing room did not wash, rinse, and sanitize any of the food contact surfaces before processing tuna and salmon.

  • The sink used to wash knives contained fish parts from previous production days and dirty washcloths. An employee was observed placing a whole fresh salmon, prior to processing, into this sink without cleaning the sink or removing the dirty washcloths.

Exclusion of Pests from a Food Plant (21 CFR § 123.11 (b)(8)]:

One electric bug zapper was next to the left hand corner of the middle fish processing table. Another bug zapper was over the second cellophane dispenser located in the warehouse outside the processing room. Both bug zappers did not have the proper equipment to catch and hold the insects after they are killed.

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 wheo you will correct any remaining violations.

This letter may not list all the deviations at your facility. You are responsible for I ensuring that your processing plant operates in compliance with the Act, the seafood HACCP Regulation and the Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent I 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. )f you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (214) 253-5220.


Michael A. Chappell
Dallas Districtdirector