Inspections, Compliance, Enforcement, and Criminal Investigations
Wimberger's Old World Bakery 3/8/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Denver District Office |
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
March 8, 2011
Ref #: DEN-11-08-WL
Mrs. Ulrike A. Wimberger, Owner
Wimberger’s Old World Bakery
2321 Bott Avenue
Colorado Springs, CO 80904
Dear Mrs. Wimberger,
On October 20-29, 2010, the U. S. Food and Drug Administration conducted an inspection of your bakery located at 2321 Bott Avenue, Colorado Springs, Colorado. The inspection found that you have serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR) Part 110 (21 CFR Part 110). These conditions cause the bread products produced at your facility 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 your bread products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act and the CGMP food regulations through links on the FDA’s homepage at http://www.fda.gov.
The significant violations observed were as follows:
You must take effective 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). However, your firm did not take effective measures to exclude pests from your processing areas as evidenced by live and dead flour beetle insects, including beetles in the larval stage, fruit flies, ants, and flies which the inspector observed on and/or in in-process bread dough product, raw ingredient containers, finished bread product, production equipment, and in the oven and production rooms.
We acknowledge the corrective actions promised in your response, dated November 11, 2010, to improve the cleaning operations in your firm. FDA recommends that after you implement the corrections stated in your response, you should evaluate the effectiveness of the corrections and make changes accordingly to your facility, equipment, and cleaning processes to ensure that pests are excluded from your facility. We recommend that you make pest control an ongoing concern. FDA will evaluate and verify all of your corrections during the next inspection.
The above violations are not intended to be an all-inclusive statement of violations that exist in your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing the recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all applicable requirements of federal law, the Act, and its implementing regulations. You should take prompt action to correct violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations noted above. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Address your reply to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at (303) 236-3046 if you have any questions about this matter.
Acting District Director