Inspections, Compliance, Enforcement, and Criminal Investigations
Superior Catering Service 31-Mar-03
Food and Drug Administration
New Orleans District Office
297 Plus Park Blvd.
Nashville, TN 37217
March 31, 2003
VIA FEDER4L EXPRESS
Mr. Connely D. Cofer, Co-Owner
Mr. Raymond H. Johnson, Co-Owner
Superior Catering Service
2103 S. Highland Park Avenue
Chattanooga, TN 37404
Warning Letter No. 03-NSV- 13
Dear Messrs. Cofer and Johnson:
An inspection of your food manufacturing facility, located at 2103 South Highland Park, Avenue, Chattanooga, TN conducted by investigators of the Food and Drug Administration (FDA) on January 14, 16, 21, 23-24, 2003, found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food [Title 21, Code of Federal Regulation (CFR), Part 110]. Also, serious deviations from 21 CFR 123, Seafood Hazard Analysis of Critical Control Point (HACCP) regulations were noted. Together, these deviations cause your food products to be adulterated as defined within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). The food products you manufacture for other vendors are in violation of 21 CFR 101, Food Labeling requirements, causing them to be misbranded as defined within the meaning of Sections 403(e) and 403(i) of the Act. You can find the Act and aforementioned regulations on the Internet through links in the FDA home page at www.fda.gov. (If you do not have access to the Internet, we will furnish you copies on request.)
Our inspection revealed numerous instances where employees handled food products in an insanitary manner, failed to wear protective outer garments while preparing meals, and wore jewelry and other objects during production. The inspection also revealed instances where foods were held at potentially dangerous temperatures inside hot boxes, and thermometers had not been routinely calibrated. Processing utensils and equipment were not properly cleaned, sanitized or maintained.
You must have a written HACCP plan to control each food safety hazard that is reasonable likely to occur, to comply with 21 CFR 123.6(b). However, you fail to have a HACCP plan to cover the hazards associated with your tuna salad product.
You must adequately monitor sanitation conditions and practices during processing to comply with 21 CFR 123.11 (b). However, your firm did not monitor employee hand washing, equipment, or utensil cleaning and sanitizing operations.
You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c).
None of your meals or sandwiches are labeled, which is a violation of 21 CFR 101, Food Labeling requirements. Since you are a food manufacturer, you must properly label each product.
The above noted observations are not intended to be an all-inclusive list of existing deficiencies. It is your responsibility to assure compliance with all requirements of the Act, including such basic and obvious violations as are listed above.
You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, such action may include seizure and/or injunction.
You should notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed. Please respond directly to Kari L. Batey, Compliance Officer, Food and Drug Administration, 297 Plus Park Boulevard, Nashville, TN 37217 or telephone (615) 781-5380, extension 112.
Carl E. Draper
Director, New Orleans District