Inspections, Compliance, Enforcement, and Criminal Investigations
Sylvester's Crawfish Processor 10-Jun-05
Department of Health and Human Services
Public Health Service
New Orleans District
June 10, 2005
WARNING LETTER NO. 2005-NOL-24
Mr. Chester Sylvester, Jr., Owner
Sylvester's Crawfish Processor
19924 Highway 182
Bunkie, Louisiana 71322
Dear Mr. Sylvester:
On April 19 and 22, 2005, United States Food and Drug Administration (FDA) investigators inspected your crawfish tail meat processing facility, located at 19924 Highway 182, Bunkie, Louisiana. We found serious deviations from the Seafood Hazard Analysis Critical Control Points (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 to have and implement a HACCP plan to comply 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 USC, Section 342(a)(4). Accordingly, your crawfish tail meat is adulterated, since it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA's Internet home page at http://www.fda.gov.
FDA issued a letter dated May 27, 2004, following an inspection of your facility in April 2004, citing many of the same violations observed during this most recent inspection. Current deviations noted during this inspection include:
1. You must conduct a hazard analysis to determine whether there are food safety hazards reasonably likely to occur and have a HACCP plan, at a minimum, listing food safety hazards reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(t) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for vacuum-packaged crawfish tail meat does not list the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation, which is reasonably likely to occur during the expected shelf-life of your product under your present practices. This was brought to your attention in FDA's letter dated May 27, 2004.
C. botulinum toxin formation would not be reasonably likely to occur and thus would not need to be included in your HACCP plan if actions such as one of the following are taken:
a. The product is sealed in packaging material that has an oxygen transmission rate of more than 10,000 cubic centimeters per square meter per 24-hour period of time (10,000 CC/M2/24hr at 24°C and 1 atm); or,
b. The product is frozen immediately after processing, maintained frozen throughout distribution, and labeled prominently with instructions to hold frozen and to thaw under refrigeration immediately before use (e.g. "Important, Keep Frozen, Thaw Under Refrigeration Immediately Before Use"); or,
c. The product bears a validated time temperature integrator (TTI), including instructions as to its interpretation, as a monitoring device to control C. botulinum toxin formation on each retail or consumer package. A TTI is a device which provides a clear indication to the retailer/consumer, by color change or other means, the product may have been exposed to a time and temperature combination and could result in an unsafe product.
2. You must implement the record keeping system you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, you did not record the time at the "Peeling & Packing" critical control point (CCP) to control toxin formation as listed in your HACCP plan for vacuum-packaged crawfish tail meat.
In addition, you did not record the internal crawfish temperature monitoring observations at the "Boiling" CCP to control pathogen survival as listed in the same HACCP plan. Specifically, you did not record the internal crawfish temperature during the cooking operation on March 14, 17, 21, 31, and April 5, 8, 15, 16, 2005. Furthermore, you did not record the internal crawfish temperatures during the following:
a. 14 out of 15 batches cooked on March 1, 2005 ;
b. 16 out of 19 batches cooked on March 4, 2005;
c. 26 out of 32 batches cooked on March 7, 2005;
d. 33 out of 44 batches cooked on March 10, 2005; and,
e. 28 out of 33 batches cooked on April 19, 2005.
3. You must verify your HACCP plan for vacuum-packaged crawfish tail meat is adequate to control food safety hazards reasonably likely to occur, and the plan is being implemented effectively, to comply with 21 CFR 123.8(a). However, your firm did not verify the HACCP plan is being implemented effectively. The dial thermometers used to monitor the internal temperature of crawfish during cooking operations were not calibrated properly. On April 19, 2005, a side-by-side comparison of your dial thermometers with an FDA thermometer was conducted in a pot of boiling water. This comparison revealed your long-stem thermometer registered 244°F, and the FDA thermometer registered 212°F. This comparison also revealed your short-stem thermometer registered 220°F. Because your long-stem thermometer was recording a temperature 32 degrees higher than the actual temperature, and your short-stem thermometer was recording a temperature eight (8) degrees higher than the actual temperature, you would not know when you had met your critical limit of an internal temperature of 180°F at the "Boiling" CCP.
Your Crawfish Cook Log, dated April 19, 2005, listed internal product temperatures of 180°F. Each temperature measurement would not have met your critical limit of an internal temperature of 180°F when a correction factor of 32°F or 8°F was subtracted from the registered temperature of your long-stem or short-stem thermometers, respectively. The internal temperature of the crawfish would have been 147° and 172°F, respectively, when the correction factor was subtracted from your reading of 180°F. The correction factor takes into account the inaccuracy of your dial thermometers revealed by the side-by-side comparison described above. A corrective action would have been needed if your dial thermometers incorrectly measured the temperature at 180°F. Calibrating your thermometers is necessary to ensure you met your critical limits and helps ensure you produce a safe product.
4. You must conduct a hazard analysis to determine whether there are food safety hazards reasonably likely to occur and have a HACCP plan, at minimum, listing the CCPs, to comply with 21 CFR 123.6(a) and (c)(2). A CCP is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for vacuum-packaged crawfish tail meat does not list the CCP of cooler storage for controlling the food safety hazards of C. botulinum growth and toxin formation. Vacuum-packaged crawfish tail meat was observed stored in the cooler covered in ice for up to three days without monitoring the presence of ice surrounding the product, and your product does not bear a TTI as described above.
5. You must have a HACCP plan, at minimum, listing monitoring procedures for each CCP, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for vacuum-packaged crawfish tail meat does not list the monitoring procedure or frequency at the peeling and packaging CCP to control toxin formation.
6. Since you chose to include corrective actions 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 vacuum-packaged crawfish tail meat at the cooking CCP to control pathogen survival is not appropriate. For example, the corrective action, "reboil", which is listed at the cooking CCP in the HACCP plan, does not ensure in-process products and/or finished products are segregated, held, and evaluated to prevent them from entering commerce if the critical limit deviation is detected after the cooking step. In addition, the corrective actions listed in your HACCP plan at the boiling, peeling and packing, and ice bath CCPs do not include provisions for correcting the cause of the deviation.
7. You must monitor sanitation conditions and practices adequately during processing to comply with 21 CFR 123.11(b). However, your firm did not adequately monitor the
prevention of cross-contamination from insanitary objects to food, as required by 21 CFR 123.11(b)(3). Specifically, employees working in direct contact with food and food contact surfaces did not take necessary precautions to protect against contamination. This was brought to your attention in FDA's letter dated May 27, 2004. Observations made during this inspection include:
a. An employee handled sacks of live, uncooked crawfish ands then handled cooked crawfish to check the internal temperature of the crawfish without washing or sanitizing his gloved hands. In addition, this same employee handled sacks of live crawfish and, without washing or sanitizing his gloved hands, handled perforated baskets of cooked crawfish when emptying them into the peeling room chute;
b. On two occasions, the cook employee used gloves to handle baskets of live crawfish and then baskets of cooked crawfish without washing or sanitizing the gloves. The same cook employee routinely placed the gloves on an unsanitized table in the cook room when not being worn. He did not wash and sanitize the gloves before using the gloves to handle perforated baskets of cooked crawfish when emptying them into the chute;
c. An employee was observed handling filled bins containing crawfish waste, a broom and dust pan to remove crawfish waste from the peeling room floor, and then supplied cooked crawfish to the peeling employees without washing or sanitizing his hands. On two occasions, he touched the cooked crawfish on the peeling table without washing or sanitizing his hands after handling an unsanitized broom and dust pan;
d. An employee routinely picked up an unsanitized hose from the floor and sprayed water into the plastic cart used to transport cooked crawfish to the peeling tables. The employee used his unsanitized thumbs over the hose and sprayed water on the cart used to transport cooked crawfish. In addition, he did not wash or sanitize all areas of the cart which contacted cooked crawfish before refilling it again;
e. Employees peeling crawfish rubbed their noses with the back of their hands and resumed peeling crawfish without washing and sanitizing their hands on four occasions; and,
f. A visitor was observed drinking a beverage in the cook room during cooking operations.
8. Your firm did not adequately monitor the conditions and cleanliness of food contact surfaces, as required by 21 CFR 123.11(b)(2). Your firm's food processing equipment is not maintained in a sanitary condition to prevent food from becoming adulterated. For example:
a. The cart used to transport cooked crawfish to the tables for peeling was covered with black residues; and,
b. Black residues were observed in the rough seam welds located on the inside portion of the chute used to guide crawfish into a cart transporting them to the peeling tables.
9. You did not monitor the exclusion of pests from the food plant, as required by 21 CFR 123.11(b)(8). Specifically, you have not taken adequate measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.
a. Two live, house-type flies were observed in the peeling room during processing. One fly landed on cooked crawfish;
b. One house-type fly was in the cook room during processing;
c. At least 30 flies were on and flying around four empty plastic waste containers located approximately 10 feet from the south peeling room door; and,
d. At least 250 flies were on and flying around crawfish waste contained in 10 plastic waste containers located approximately 15 feet from the south peeling room door.
10. You failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically:
a. The south peeling room door was ill-fitted in the closed position creating an opening approximately 1/4" x 3' between the floor and the bottom of the door;
b. The east cook room door was ill-fitted in the closed position creating an opening approximately 2" x 7' along the bottom of the door leading directly into the peeling room; and,
c. The west cook room door was open creating an opening approximately 3' x 7' leading directly to the outside. This door remained open during the entire day's production on April 19, 2005.
11. You failed to provide adequate sanitizing agents, as required by 21 CFR 110.35(d)(5). Specifically, on April 19, 2005, the hand sanitizers used by your employees had a nondetectable amount of free chlorine when tested.
12. You did not take reasonable measures and precautions to ensure persons working in direct contact with food wore appropriate hair nets, headbands, caps, beard covers or other effective hair restraints, as required by 21 CFR 110.10(b)(6). Specifically, five employees peeling crawfish did not wear beard covers.
13. You failed to monitor the safety of the well water used for washing processing equipment, as required by 21 CFR 123.11(b)(1).
We may take further action if you do not promptly correct these violations. For instance, we may seize your products and/or enjoin your firm from operating. You made a verbal commitment to correct the observed deficiencies at the close of the inspection.
We received your letter, on June 6, 2005, written in response to the Form FDA 483, Inspectional Observations, issued to you on April 22, 2005. We evaluated your response and found it inadequate since it did not specifically address the deficiencies listed on the Form FDA 483. For example:
You did not provide examples of monitoring records or CCPs to support your corrective actions;
You have not provided any records demonstrating the thermometers have been calibrated;
You have not provided a date for the purchase of a new cart or removal of rough welded seams of the chute used to transport the crawfish; and,
Your response does not include your instruction on proper ways to sanitize hands.
Please respond in writing within fifteen (15) working days from your receipt of this letter outlining the specific steps you are taking to correct all of the deviations listed on the Form FDA 483 issued to you at the conclusion of the inspection. You should include in your response any documentation, such as your revised HACCP plan, copies of temperature monitoring records, or other useful information to assist us in evaluating your corrections. In addition, please provide your actions regarding the crawfish tail meat which were monitored during the cooking operations with thermometers that were not properly calibrated. If you choose to remove this product from the market, discuss recall procedures in your response. If you cannot complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
This letter is not intended to be an all-inclusive list of the deviations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, Seafood HACCP regulation, and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a direct responsibility to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S . Food and Drug Administration, New Orleans District, Attention: Mark W. Rivero, Compliance Officer, 6600 Plaza Drive, Suite 400, New Orleans, Louisiana 70127. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 253-4519.
H. Tyler Thornburg
New Orleans District