C & B Croissants Corporation FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

c. Front and back roll-up doors remained open during the first day of the inspection, with no barriers to prevent pests and vermin from entering the warehouse areas in both the front and the rear of the building.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations and to prevent these violations or other similar violations from occurring again. Include documentation, including photographs, corrective actions you have taken to date, or other useful information that would assist us in evaluating your corrections. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the date by which you will have completed the corrections.

Potential Health Risks

During an inspection of your firm located at 1339 W. Gaylord St., Long Beach, CA on October 25 through November 4, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a variety of frozen croissants. During the inspection, the investigator found violations of the Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they ma

cc:David M. Mazzera, PhD, Chief, Food and Drug BranchCalifornia Department of Public Health1500 Capitol Avenue, MS-7602P.O. Box 997435Sacramento, CA 95899-7435

Regulatory Context

Violations revealed during the inspection include, but are not limited to, the following:

1. Your firm failed to take measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigator discovered evidence of insect and rodent activity near foods stored in your food processing facility. For example, the following items were discovered in the production areas of the bakery during the inspection:

2. Your firm failed to handle work-in-process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically,