Inspections, Compliance, Enforcement, and Criminal Investigations
Barney's Weir Cove Bakery 27-Apr-05
Department of Health and Human Services
Public Health Service
Baltimore District Office
April 27, 2005
RETURN RECEIPT REQUESTED
Mr. George M. Barney
Barney's Weir Cove Bakery
1242 Pennsylvania Avenue
Weirton, WV 26062
Dear Mr. Barney:
Inspections of your bakery operation located at 1242 Pennsylvania Ave, Weirton, WV on May 10 through May 12, 2004 and January 31 through February 2, 2005, revealed a serious violation of the Federal Food, Drug, and Cosmetic Act (the Act). The investigator documented significant deviations from the food labeling regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101), causing your packaged Italian bread products to be misbranded within the meaning of Section 403 of the Act (21 U.S.C. 343).
Our review of the labeling of your "DiCarlo's Italian Bread" and "The Real Italian Bread" bakery products revealed the products are misbranded in that their labeling fails to bear nutrition labeling as required by Section 403(q)(1) of the Act (2I U.S.C. 343(q)(1)) and 21 CFR 101.9. Because your firm distributes approximately [redacted] units of Italian bread a day, which amounts to [redacted] units per year, this product does not qualify for exemption from nutritional labeling as a low volume food of a small business (21 CFR 101.9(j)(18)(ii)). Therefore, the packaged Italian bread distributed by your firm must bear nutrition labeling in the format prescribed in 21 CFR 101.9(d). According to our records, this deviation was brought to your attention during both inspections noted above.
This letter may not list all deficiencies of your products and their labeling. It is your responsibility to ensure that all products manufactured and labeled by your firm are in compliance with the Act and its implementing regulations. The Act and FDA regulations are available on FDA's website at www.fda.gov.
You should take prompt action to correct these deviations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. The Act provides for the seizure of misbranded products and/or injunction against the manufacturer and/or distributor of misbranded products.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence of similar violations. Your response should outline the specific things that you are doing to correct these deviations. You should include in your response documentation and written verification procedures or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining deviations.
Your reply should be sent to the Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, Attention: Steven B. Barber, Compliance Officer . Mr. Barber can be reached at (410) 779-5134