Inspections, Compliance, Enforcement, and Criminal Investigations
Louisiana Fine Foods, Inc. 11-Aug-04
Department of Health and Human Services
Public Health Service
August 11, 2004
RETURN RECEIPT REQUESTED
Mr. James G. Gossen, President
Louisiana Fine Foods, Inc.
4410 West 12th Street
Houston, Texas 77055
Dear Mr. Gossen:
We inspected your firm, Louisiana Fine Foods, Inc., located at 4410 West 12th Street, Houston, Texas 77055 on June 28-July 2, 2004. Our inspection found that your firm has serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of this part, renders the 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 crabmeat; fresh, vacuum packed founder; and fresh tuna, are all adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the seafood HACCP regulations through links in FDA’s home page at www.fda.gov.
The deviations that were found during the inspection were as follows:
1. Pursuant to 21 CFR 123.6(a), your firm is required to conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and to identify the preventive measures that your firm can apply to control those hazards. Also, pursuant to 21 CFR 123.6(b), your firm must have and implement a written HAACP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur.
Your firm, however, does not have a HACCP plan to control the following food safety hazards that are reasonably likely to occur: pathogen growth in pasteurized crabmeat and CIostridium botulinurn in fresh, vacuum packed flounder.
2. Pursuant to 21 CFR 123.6(c)(4), your firm must have a HACCP plan that, at a minimum, lists the monitoring procedures for each critical control point. However, your firm lists monitoring procedures/frequencies at the Processing and Storage critical control points that are not adequate to control histamine forming bacteria or pathogen growth.
Your HACCP plan for Tuna, Mahi, Swordfish, and Amberjack that are histamine forming species has listed under monitoring for Processing “keep fish on ice after processed and packed” and has listed under Storage “adequacy of ice surrounding product.” Your HACCP plan sets the critical limit that the product is not to be exposed to temperatures above 40 degrees Fahrenheit for more than four hours cumulatively and that the product is to be packed in ice for both processing and storage. However, no times/temperatures are recorded on the monitoring records, only that the ice is “OK.” In addition, the frequency listed under monitoring is "every lot” but the ice is checked every morning and afternoon. Therefore, the monitoring procedures/frequencies do not address the amount of time the histamine producing species is exposed to temperatures above 40 degrees Fahrenheit during processing or the assurance that the cold storage is maintained at 40 degrees Fahrenheit or less to control histamine forming bacteria or pathogen growth in fresh/pasteurized crabmeat.
3. Pursuant to 21 CFR 123.11(b), your firm must monitor sanitation conditions and practices during processing with sufficient frequency to ensure conformance with 21 CFR Part 110. However, your firm has demonstrated to the investigators during the current inspection and the previous inspection conducted on 11/17/2003, that you are not monitoring and maintaining sanitation conditions as they relate to seafood HACCP and ensuring conformance to 21 CFR Part 110. Your firm’s Daily Sanitation Report dated 6/28/04 has all the required items checked off in the “shut down” column as being cleaned and sanitized, signed by the supervisor, and reviewed/signed by a second reviewer. The following conditions were observed on 6/29/2004:
Safety of Water that Comes in Contact with Food [21 CFR 123.11(b)(1)]:
- Embedded slime was observed in ice used to cover and cool packaged gumbo stock;
- Dirty ice was observed being used on ready to ship salmon.
Condition and Cleanliness of Food Contact Surfaces [21 CFR 123.11 (b)(2)]:
- Cutting board was observed on the floor leaning against the wall and was in contact with standing water;
- Processing table contained cutting boards that were not smooth preventing adequate cleaning and sanitation;
- Pieces of crab shells and pieces of raw fish were observed on processing tables the next morning after overnight cleaning was performed;
- Processing utensils were observed stored in water overnight that did not contain sanitizer and were used in the process with only a water rinse.
Prevention of Cross-Contamination from Insanitary Objects [21 CFR 123.11(b)(3)]:
- Employees are allowed to cut and process fish using the same gloves used in the pre-cleaning process:
- Processing hose used to transfer product from the North kettle to the pumping room for packing was stored overnight uncapped;
- An employee was observed pressure washing equipment and wall with water that splashed into the North kettle where gumbo stock was cooking;
- Employees were allowed to enter the processing room without wearing hair restraints:
- Raw vegetables were observed being washed in the equipment wash sink;
- Pieces of rust were observed in standing water in uncovered raw onions;
- Water with leftover product was allowed to stand in the North kettle overnight and the “Daily Sanitation Report” had this equipment checked as being okay;
- Cleaning procedure for the hose and pump used to transfer the gumbo stock was inadequate.
Protection of Food from Adulteration with Lubricants, Cleaning Compounds, Sanitizing Agents, Condensate, and other Chemical, Physical, and Biological Contaminants [21 CFR 123.11 (b)(5)]:
- An employee dropped a green pepper onto the processing table when another employee placed a bottle of bleach next to the pepper, leaving a puddle of bleach that made contact with the pepper. The pepper was picked up and placed into a bin with the rest of the green peppers;
- Condensation from cooling unit with a heavy dust build-up was observed dripping onto uncovered stuffed snapper;
- Equipment used in processing had a wide area covered with rust
- Condensation was observed dripping from an air cooling unit onto uncovered flounder waiting to be vacuum packaged;
- Electrical plugs hanging over cutting tables have a large accumulation of filth that drips onto tables during processing of fresh fish;
- Rust was observed on ceiling, beams, light fixtures, and support poles that make contact with ice used for processing.
Proper Labeling, Storage, and Use of Toxic Compounds [21 CFR 123.11 (b)(6)]:
- Bucket containing cleaning solutions was stored on a pallet with raw vegetables;
Exclusion of Pests from a Food Plant [21 CFR 123.11(b)(8)]:
- Light shields containing water and dead flies were observed dripping onto uncovered stuffed snapper;
- Dock door next to ice maker room was observed with a six inch gap at the bottom of the door:
- Firm did not have rat traps in the dock area prior to this inspection.
4. Pursuant to 21 CFR 123.8(c), if your firm does not have a HACCP plan because a hazard analysis has revealed no food safety hazards are likely to occur, you must reassess the adequacy of the hazard analysis whenever there are any changes that could reasonably affect whether a food safety hazard now exists. The reassessment should be performed by an individual who has been trained in accordance with 21 CFR 123.10.
However, at your firm, it was observed that the fresh, vacuum packed Flounder was not frozen immediately after processing and was still not frozen by noon the following day. It was determined that previously your firm had vacuum packed frozen fish and that process did not require a HACCP plan. Therefore, the process should have been re-evaluated when it was changed to determine if a food safety hazard now exists and if a HACCP plan needed to be written. The food safety hazard that is most likely to occur is the growth of Clostridium botulinum that under anaerobic conditions produces a deadly toxin when fish is not frozen immediately after vacuum packaging.
5. Pursuant to 21 CFR 123.6(b), your firm must implement the record keeping system listed in your HACCP plan. However, your HACCP plan for Fresh Crabmeat lists under the heading of monitoring the use of a data logger to continuously monitor the temperature and under the heading of records maintain data logger printout. Your HACCP plan for Tuna, Mahi, Swordfish, and Amberjack lists under verification the cooler temperature recorder. The data logger records temperatures every hour. Your firm could not retrieve any temperatures from the weekends or any of the times between the one hour intervals that are recorded by the data logger. Therefore, your ftnn did not implement the record keeping system of continuous monitoring by the data logger as listed in your HACCP plans.
6. Pursuant to 21 CFR 123.6(c)(7), your firm’s HAACP plan must provide for a recordkeeping system that documents the monitoring of the critical control points (CCPs). Moreover, the records from such monitoring must contain the actual values and observations obtained during monitoring. Your firm, however, did not record monitoring observations at the receiving CCPs or the storage CCPs to control histamine forming bacteria listed in your HACCP plan for Tuna, Mahi, Swordfish, and Amberjack; or the actual cook time for gumbo stock listed in your HACCP plan.
The Daily HACCP Receiving Report dated 6/29/04 had fresh tuna received, checked for ice, and accepted. The case of fresh tuna in the storage cooler was still intact and unopened. The employee had checked “accepted” for received and “Yes” for the presence of ice but the case of fresh tuna was still intact and unopened in the cooler. In addition, on 6/29/04, a Mahi was discovered lying on top of the ice in a carton instead of being covered with ice in the storage cooler. On the Storage Check Form for 6/29/04, the employee had checked that ice was “OK” when there was not adequate ice. Therefore, the person performing the visual check for adequacy of ice upon receipt and in the storage cooler is not recording the actual observations.
Additionally, during the preparation of the Gumbo Stock, water is added several times and that stops the boiling process. The cook records on the Kettle Cook Time log the total time of four hours. The recorded time should only be the actual boiling time. In addition, the HACCP plan for the Gumbo lists only one minute of boiling time required after all ingredients are added. The actual cooking time values are not recorded by the cook.
7. Pursuant to 21 CFR 123.8(a)(2)(ii), your firm must verify that your firm’s HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented by ongoing verification activities including the calibration of process-monitoring instruments. However, your firm did not properly calibrate temperature probes used for monitoring temperatures listed as CCPs in your HACCP plans throughout your facility.
Your firm did not place both the NIST thermometer and the temperature probe of the data logger in the water bath at the same time in the same location such as in the cooler. In addition, no adjustment is made to the data logger and there is no documentation that the variances of degrees between the NIST thermometer and the temperature probe are subtracted from the temperatures recorded by the data logger.
We received your July 9, 2004, response to the FDA 483, Inspectional Observations that the FDA investigators issued at the conclusion of the most recent inspection of your firm. We have completed our review of your response and have determined that your response is inadequate to address all the violations that FDA documented at your firm. Although you state that several of the violations have been corrected: some of these corrections can only be verified at a follow-up inspection of your firm. In addition, you did not submit the HACCP plan that you have written and implemented for pasteurized crabmeat with your response or any documentation that would verify corrections, e.g., temperature print-outs from the data logger, temperature probe calibrations, and training records.
We may take further action, if you do not promptly correct these violations. For instance, we may initiate regulatory action without further informal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation, such as, your HACCP plans, copies of all related temperature monitoring records and corrective actions, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations and the Good Manufacturing Practice regulations (21 CFR Part 140). 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 any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (214) 253-5312.
Michael A. Chappell
Dallas District Director