Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
6000 Metro Drive, Suite 101
Baltimore, MD 21215
CMS # 395943
April 23, 2013
Mr. Michael W. Harris and Mrs. Pamela J. Harris, Co-Owners
A & M Bakery, Inc.
128 South 3rd Street
Clarksburg, WV 26301
Dear Mr. & Mrs. Harris:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 128 South 3rd St., Clarksburg, WV, 26301, March 15, 18, & 27/2013. Your facility is a manufacturer and distributor of bread, cookies, pastries and pepperoni rolls.
During our inspection, an FDA investigator documented serious violations of the Current Good Manufacturing Practice (cGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause your bakery products, produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
The specific cGMP violations observed during the inspection include, but are not limited to the following:
1. Buildings and Facilities: Sanitation Operations (21 CFR 110 Subpart B)
a. Not excluding pests specifically flies from being in the manufacturing area as well as on bakery products.
b. Failure to properly store toxic cleaning products away from bakery products and equipment.
c. Improper use of cleaning and sanitizing agents in regard to effective concentration and use on equipment.
d. Failure to maintain building in a sufficient state of repair.
2. Personnel (21 CFR 110 Subpart A)
a. Employees observed to be drinking and smoking cigarettes in areas where foods are exposed and equipment or utensils are washed.
b. Failure of employees to wear hair nets and beard covers while assembling and packaging bakery products.
c. Failure of employees to wash their hands after coming into contact with trash and soiled books prior to resuming hands on work with bakery products.
d. Employee use of soiled gloves when handling bakery products.
e. Personal employee clothing such as hats, coats and shoes being stored alongside manufacturing equipment.
3. Buildings and Facilities: Plants and Grounds (21 CFR 110 Subpart B)
a. Failure to provide safety-type bulbs and lighting fixtures suspended over exposed food.
b. Building not constructed to in a manner that allows adequate cleaning and to be kept clean.
4. Equipment: Equipment and Utensils (21 CFR 110 Subpart C)
a. Failure to maintain equipment such as wooden tables used to assemble bakery products in a manner to facilitate cleaning.
b. Failure to have smoothly bonded or well maintained seams on food contact surfaces of equipment such as mixing bowls to minimize product buildup and or growth of microorganisms.
5. Production and Process Controls: Processes and Controls (21 CFR 110 Subpart E)
a. Failure to store raw materials in a manner that protects against contamination. Such as, cartons of whole eggs stored on the floor and BBS shortening stored on a shelf with the lid of a garbage can leaning on the container.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your manufacturing operations are in compliance with the Act and cGMPs for Food (21 CFR 110). It is also your responsibility to assure all your products are in compliance with all applicable federal regulations enforced by FDA.
You should take prompt action to correct these violations noted in this letter and you should establish procedures to ensure such violations do not recur. Failure to promptly do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.
You should notify this office in writing 15 working days from receipt of this letter of the specific steps you have taken to prevent recurrence. You should include in your response documentation, such as, copies of forms submitted to the FDA, and other useful information to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
If you have any questions regarding the contents of this letter, please contact CDR Rochelle B. Young at 410-779-5437.