Inspections, Compliance, Enforcement, and Criminal Investigations
Princess Brandy Co., Inc. 05-Feb-07
Department of Health and Human Services
Public Health Service
Los Angeles District Office
RETURN RECEIPT REOUESTED
February 5, 2007
Ms . Michelle P. Satren, President
Princess Brandy Co., Inc. dba The Incredible Cheesecake Company
3161 Adams Avenue
San Diego, CA 92116-1638
Dear Ms . Satren:
We inspected your food processing facility, located at 3161 Adams Avenue, San Diego, CA 92116-1638 on October 16-17, 2006. We found that you have serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110. These violations cause your products processed in your facility, such as ready-to-eat cheesecakes, muffins, cakes and peanut butter bars, to be 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), 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, and the CGMP regulation for foods through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection you were issued a Form FDA-483 (copy attached) which listed a number of insanitary conditions present in the facility at the time of the inspection. The following is the list of the insanitary conditions observed during the inspection. The specific CGMP cites are referenced after each violation listed below. Your significant violations were as follows:
1. Effective measures are not being taken to exclude pests from the processing areas and protect against contamination of food on the premises by pests [21 CFR 110.35(c)].
a. On 10/16/06 there were rodent excreta pellets Too Numerous To Count (TNTC) throughout your processing facility and food storage areas, including on a baking rack in your processing room, along the north-west processing room wall behind processing tables, along the west processing room wall behind an oven and a walk-in cooler, on the top of the west wall walk-in cooler, in your dry storage room in the vicinity of open boxes of chocolate chips, and in your processing area mop closet.
b. On 10/16/06 there were dead ants TNTC on a processing room wall that had bags of sugar and flour stored against it.
c. On 10/16/06 there were numerous dead insects including a cockroach on your processing room floor.
2. Failure to provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. [21 CFR 110.20(b)(1)].
a. There is a cluttered office / storage area accessed through an enclosed storage area directly behind your processing facility, and an area behind strip curtains in the enclosed storage area is also cluttered. Both of these cluttered areas provide harborage for rodents as evidenced by rodent excreta pellets TNTC throughout the office / storage area and in the area behind the strip curtains in the enclosed storage area.
3. Failure to provide safety-type light bulbs suspended overexposed food [21 CFR 110.20(b)(5)]. a. On 10/16/06 there were 12 unprotected glass fluorescent light tubes directly overexposed in-process cheesecakes in your processing area.
4. Failure to store finished food under conditions that would protect against physical, chemical, and microbial contamination [21 CFR 110.93].
a. On 10/16/06 unprotected cakes were stored directly under an area of dripping condensate in your freezer.
5. Personal clothing and belongings were stored in an area where food is exposed [21 CFR 110.10(b)(7)].
a. On 10/16/06 numerous personal items were stored with food and food processing equipment including insulin for injection and an open beverage stored directly above finished cheesecakes in your walk-in cooler, a box of syringes and drinking cups stored on the lower shelf of a processing table, a yogurt drink with processing equipment on the lower shelf of a processing table, a bottle of the pain reliever Advil stored alongside cheesecake baking pans on the lower shelf of a processing table, and a jacket, portable CD player, and headphones stored in direct contact with processing equipment on the lower shelf of a processing table.
6. Lack of a sanitary towel service or suitable hand drying devices [21 CFR 110.37(e)(3)].
a. On 10/16/06 there were no hand drying towels in your processing area restroom.
7. The procedure used for cleaning of equipment and utensils has not been shown to provide adequate sanitizing treatment [21 CFR 110.35(d)(5)].
a. On 10/16/06 utensils and baking pans were hand washed with detergent and rinsed with tap water in your two-compartment dishwashing sink; the utensils and baking pans were not sanitized.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that you operate your processing plant in compliance with the Act, and the Current Good Manufacturing Practice regulation (21 CFR Part 110), as applicable.
You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and time within which the corrections will be implemented. Corrective actions should also indicate the person responsible for effecting correction, and include any supporting documentation indicating correction has been achieved.
Your written reply should be addressed to:
Pamela B. Schweikert, Director, Compliance Branch
U. S. Food and Drug Administration
Irvine, California 92612-2445
If you have questions regarding any issue in this letter, please contact Robert McNab, Compliance Officer at (949) 608-4409.
In addition, we request that you contact the District Office to schedule a meeting between you and FDA management here at our District Office located in Irvine, California to discuss the current findings. Please contact Mr. McNab at the above phone number to schedule this meeting as soon as possible.
Alonza E. Cruse
cc: Department of Health Services
Attn: Chief, Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA 95899-7413