Inspections, Compliance, Enforcement, and Criminal Investigations
Capitol Cake Co. 12-Aug-08
Department of Health and Human Services
Public Health Service
Baltimore District Office
FEI #: 1121988
CMS #: 11706
August 12, 2008
RETURN RECEIPT REQUESTED
Mr. John T. Kunkel
Capitol Cake Co.
1400 Russell Street
Baltimore, MD 21230
Dear Mr. Kunkel:
The Food and Drug Administration (FDA) conducted an inspection of your food storage warehouse, located at 1400 Russell Street, Baltimore, Maryland from May 12, 2008 to May 30, 2008. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Our investigators' observations showed ingredients and finished food products that had been held in a facility whereby they may have become contaminated with filth. Food is adulterated under section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act), if it is prepared, packed or held under insanitary conditions whereby it may become contaminated with filth.
The following are your violations:
1. In order to comply with 21 CFR 110.35(c), no pests are allowed in any area of a food plant. Further, effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests.
However, FDA investigators observed the following evidence of a lack of pest control:
• live rodents observed along side a rodent trap, running under pallets containing finished food products and collapsed boxes used by your firm, and a live rodent that you brushed off of your shoulder onto the floor, and then kicked under a pallet holding finished food products;
• a live bird flying inside the storage area in close proximity to boxes used to hold finished food product, plastic wrap used in shipping, and idle manufacturing equipment
• dead rodents on a rack containing finished food products, on an unused metal pan, and inside several rodent traps;
• apparent rodent urine stains, rodent gnawed holes, and rodent excreta pellets (REP) observed on/in multiple paper bags containing both finished food products and raw materials used by your firm; and
• large numbers of REPs observed throughout your firm found next to and under pallets containing finished food product, raw materials used by your firm, packaging materials used by your firm, and manufacturing equipment.
2. In order to comply with 21 CFR 110 .20(b)(7), adequate screening or other protection against pests must be provided.
However, FDA investigators observed that the loading dock doors were open, offering easy entry for pests into your warehouse.
3. In order to comply with 21 CFR 110.35(a), buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act.
However, FDA investigators observed the following evidence of your disregard of proper warehouse repair which directly relates to possible food adulteration:
• holes observed in the warehouse walls and floor, and a gap that extended in the east wall inside the storage area; and
• apparent REPs found inside and around the above mentioned holes.
This letter may not list all the violations at your facility. You are responsible for ensuring that your warehouse operates in compliance with the Act and the CGMP regulation for foods (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We strongly recommend you determine the cause(s) of the rodent/pest infestation, and take all necessary corrective actions. Failure to implement lasting corrective action may result in regulatory action being initiated by FDA without further notice. This action may include seizure and/or injunction against you and your company.
We acknowledge receipt of your response dated June 5, 2008 outlining corrections. During the inspection, the investigator verified the destruction of product contaminated with rodent filth, the construction of the new wall along the east wall, the storage of finished product and equipment at least 18 inches from the walls, and the discard of all home improvement materials and all non-usable equipment. Although you packed the holes along the east wall with copper wire, this is not a completed correction; therefore, we will verify the sealing of the holes with cement during the next inspection.
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation such as certification of actions performed by a licensed exterminator, actions performed to control the unauthorized entering of pests, plans on how you plan to protect food products from possible contamination, and/or any 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 violations.
Please send your reply to the Food and Drug Administration, Attention: Kirk D. Sooter, Compliance Branch Director at the address above. If you have questions regarding any issues in this letter, please contact Mr. Sooter at (410) 779-5412.
Cc: Baltimore City Health Department
Attn: Bureau of Food Control
210 Guilford Avenue
Baltimore, MD 21202