- M & C Catering LLC
- Issuing Office:
- Atlanta District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Atlanta District Office|
60 8th St., NE
Atlanta, GA 30309
July 29, 2013
Michael R. Shaughnessy, Owner
M & C Catering
dba Mike's Peanuts
125 Hemphill Court
Summerville, SC 29483
Dear Mr. Shaughnessy,
On May 2-8, 2013, the U.S. Food & Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 125 Hemphill Court, Summerville, SC. The FDA investigator observed serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulations, found in Title 21 of the Code of Federal Regulations Part 110 (21 CFR 110). The violations, which include evidence of rodent activity, render the products held at your facility adulterated within the meaning of Section 402(a)(4) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 United States Code (U.S.C) § 342(a)(4)] 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 pertinent FDA regulations through links on FDA's website at www.fda.gov.
The serious CGMP violations noted during the inspection were outlined on a FORM FDA 483, Inspectional Observations, issued to you at the close of the inspection. Those violations include the following:
1. You failed to manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms as required by 21 CFR 110.80(b)(2). Specifically, the cooking process for the boiled peanuts includes an extended hold time in the cook kettle without the use of a heating or cold holding source. This extended hold time of (b)(4) hours is conducted after initial boiling and prior to the final boil before final packaging.
2. Your firm has failed to use utensils that are made of materials or are designed to allow proper cleaning, as required by 21 CFR 110.40(a). Specifically, you use a wooden paddle to stir boiled peanuts during processing that is constructed of wood that is not a material that is able to be easily cleaned and sanitized.
3. Your firm failed to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination as required by 21 CFR 110.35(e). Specifically, the storage racks used for storing clean pans, utensils, and uncovered bins filled with finished product were visibly contaminated with what appeared to be food remnants, oil, and debris.
4. Your firm does not apply procedures that provide adequate cleaning and sanitizing of equipment as required by 21 CFR 110.35(d)(5). Specifically, during the inspection the FDA investigator observed the use of (b)(4) to clean and sanitize food contact surfaces, however, it does not contain at least 200 ppm chlorine needed to be an effective sanitizer. When this cleaner was tested with a chlorine test strip during the inspection, there was no color change on the strip that indicated no free-chlorine was present.
5. Your firm failed to properly identify toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food-contact surfaces and food-packaging materials as required by 21 CFR 110.35(b)(2). Specifically, there were at least three (3) unlabeled chemical spray bottles inside the chemical storage cabinet, the contents of which you were unable to identify.
6. You failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). Specifically, during the inspection, the FDA investigator observed:
• rodent excreta pellets, too numerous to count, and debris on the floor in the plumbing access room which was located adjacent to the processing area and employee restroom, on the east comer of the building.
• rodent excreta pellets, too numerous to count, under the storage racks in the processing room which are used for storing finished product containers and storage bins.
• at least ten (10) rodent excreta pellets under the storage racks in the processing room where finished product bins and clean pans and utensils are stored.
• at least two (2) rodent excreta pellets on the floor in the employee restroom.
• at least two (2) dead cockroaches in the firm 's office. The office is located adjacent to the processing room, and the office door was observed open during the inspection.
• one (1) dead cockroach under the storage racks in the processing room where finished product bins and clean pans and utensils are stored.
7. You failed to provide facilities with sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations, to comply with 21 CFR 110.20(b)(1). Specifically, there was excessive overcrowding of equipment and other items to include a lawn mower and a hot dog warmer on the facility floor and tools that were stored on storage racks which prohibits inspection for pest control and sanitation purposes. They also provide harborage areas for rodents and other vermin within the facility.
8. You failed to maintain buildings, fixtures, and physical facilities in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a). Specifically, the FDA investigator observed:
• an active ceiling leak from the ceiling which was observed to be approximately one (1) foot from the processing table.
• an active ceiling leak in the processing room directly above food packaging materials and packaged finished product.
• evidence of recent ceiling leak from the presence of water and apparent discoloration on the floor in the processing room located approximately six (6) inches from the storage racks used for storing clean stainless steel pans, plastic bins, and finished product.
• dirt, debris, and an apparent dried water leak on the floor located under the storage racks and food spatter on the wall behind the storage racks which are used for storing finished product containers and storage bins in the processing room.
• at least two (2) disposable absorbent pads filled with water, dirt, and debris on the floor used for catching the water from the ceiling leaks in the processing room.
9. Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the FDA investigator observed:
• the screened front door located adjacent to the metal roll-up door had an approximate six (6) inch tear along the frame of the door. There was no other barrier to prevent the entry of pests through the tom screen as the exterior front door was observed to be left open throughout the inspection.
• the metal roll-up door was observed to have gaps along the sides and bottom measuring approximately one-quarter to one-half of an inch.
• there was an approximate two (2) by three (3) inch gap in the wall inside the plumbing access room located adjacent to the processing area and employee restroom on the east corner of the building.
• there was an approximate two (2) by two (2) inch gap in the wall inside the plumbing access room around two (2) flexible water hose lines.
We acknowledge that your firm initiated corrective actions prior to the close of the inspection to address some of the objectionable observations noted. For example, we are aware that you cleaned the processing room, you are using an appropriate sanitizing solution, and you have either labeled or removed the unlabeled chemical spray bottles. We also acknowledge receipt of your May 16, 2013 response to the FORM FDA 483. The corrections that you have described in your response were deemed inadequate in that no supporting evidence such as photographs or documentation were provided which would enable us to more fully evaluate your corrections. Without such documentation we cannot determine the adequacy of your corrections and response. It is also important for you to not only correct the observed deficiencies but to also correct the root causes for those deficiencies to ensure the corrections are long lasting and effective.
Neither this letter nor the FORM FDA 483 is intended to be an all-inclusive statement of the violations that exist at your firm. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act and pertinent FDA regulations. You should take prompt actions to correct the violations cited in this letter. Failure to promptly and adequately correct these violations may result in FDA initiation of regulatory actions, but not limited to, seizure of your products or injunction.
Section 743 ofthe Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determining whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-3l(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or plan to take to correct the current violations and prevent similar ones. Include the timeframe within which the corrections will be completed and documentation that will effectively assist us in evaluating the adequacy of the corrections, such as photographs. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the timeframe within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have any questions, please contact Mrs. King at 843-746-2990 or write her at the noted address.
John R. Gridley