Inspections, Compliance, Enforcement, and Criminal Investigations
Lsg Sky Chefs, Inc
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204·3128
November 9, 2010
RETURN RECEIPT REQUESTED
Sondra Lehman, Chief Operations Officer
LSG Sky Chefs, Inc.
6191 N. Highway 161
Irving, Texas 75038
Dear Ms. Lehman:
We inspected your facility, located at 9919 Service Avenue, Austin, Texas, on June 28-29, 2010. 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 (cGMP) 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 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 crab cakes and tuna on wheat sandwiches 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, the food cGMP 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 a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point 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 "Fully cooked non-shelf stable seafood items," namely crab cakes, does not list the critical control points of:
a) Receiving of the refrigerated pasteurized crab meat;
b) Refrigerated storage of the canned pasteurized crab meat;
c) Refrigerated storage of finished crab to control the food safety hazard of pathogen growth and toxin formation;
and your firm's HACCP plan for "Amenable Hand Held Products Process type-RTE - Fully Cooked, non shelf stable meat and poultry products," namely Tuna on Wheat Sandwich, does not list the critical control points of refrigerated storage of the finished product.
We received your action plan, dated July 1, 2010, which Todd Kocorowski sent to Investigator Martha Baldwin bye-mail on July 2, 2010. The action plan describes actions your firm has taken to address observations cited on the FDA 483 issued at the close of the inspection. In response to this observation, your action plan specifies that your firm has reevaluated the HACCP plan for crab cakes. The HACCP plan now includes critical control points for receiving crab and continuous temperature monitoring of crab stored in your cooler. Further, your firm has added a critical control point for allergens.
Your action plan did not include a copy of your new, approved, HACCP plan. We, therefore, cannot fully assess the adequacy of your corrective actions. Further, your action plan did not include evidence that your corrective actions have been implemented. Such evidence could include copies of newly implemented HACCP records from a minimum of five production days.
2. You must have a HACCP plan that, at a 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 plan for "Fully cooked non-shelf stable seafood items," namely crab cakes, lists the critical limits, "Internal temperature must reach (b)(4) deg. F for at least. (b)(4) sec." at the Cooking critical control point to control pathogens in ready to eat crab cakes. Your critical limit is insufficient to control the hazard of pathogen survival. Specifically, Listeria monocytogenes, Chapter 16 of the Fish and Fisheries Product Hazards & Control Guidance recommends that cook processes for ready-to-eat fishery product achieve a 60 reduction in Listeria monocytogenes.
In addition, your listed monitoring procedure and records do not show how your time critical limit is being met. If time is a critical factor, then you should monitor the starting and end point to show that the critical limit has been met. If a scientific study has been conducted to show that when a specific temperature is achieved and a 6D reduction of Listeria monocytogenes is achieved, monitoring time in addition to end product temperature may not be necessary.
Your firm's action plan, dated July 1, 2010, specifies that your firm has verified the HACCP plan for crab cakes to include a critical limit for cooking crab cakes to an internal temperature of (b)(4) F. However, your action plan did not include a copy of your new, approved, HACCP plan or evidence that your corrective action has been implemented. Such evidence could include copies of newly implemented HACCP records from a minimum of five production days. We, therefore, cannot fully assess the adequacy of your corrective actions.
3. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonable likely to occur and have a HACCP plan that at a minimum lists the critical control points to comply with 21 CFR 123.6(a) and (c)(1). However, your firm's HACCP plan for "Fully cooked non-shelf stable seafood items," namely Crab Cakes does not list the food safety hazard of allergens.
Additionally, please note that while your HACCP plan for Tuna on Wheat Sandwich includes the food safety hazard of allergens, the allergen of concern appears to be specific to fish. Our label review has determined that other allergens and food tolerance substances are present in the other sandwich ingredients (e.g., allergens - egg, soy, wheat, dairy; food intolerances substances - sodium sulfite and disodium metabisulfite).
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 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response, documentation and 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.
Your reply should be directed to Sherrie L. Krolczyk, Compliance Officer, at the address indicated on the letterhead. If you have questions regarding any issues in this letter, please contact Sherrie L. Krolczyk at (214) 253-5312.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
cc: Todd J. Kocorowski, General Manger
LSG Sky Chefs, Inc.
9919 Service Avenue,
Austin, Texas 78719