Public Health Service Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Delivery Signature Requested
March 3, 2015
Mr. Abdul Karim Baghdadi
Sina Bakery, Inc.
1250 Harter Avenue, Suite C
Woodland, CA 95776
Dear Mr. Baghdadi;
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1250 Harter Avenue, Suite C, Woodland CA 95776, from December 15, 2014 to December 17, 2014. The inspection found significant deviations from FDA’s regulations for Current Good Manufacturing Practice (CGMP) in the manufacturing, packing, or holding of human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These deviations cause the foods manufactured 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 they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You may find the Act and FDA’s implementing regulations through links on FDA’s home page at www.fda.gov.
Specifically, our inspection of your facility revealed the following deviations from CGMP regulations:
Your firm failed to implement effective measures to exclude pests from the processing areas as required by 21 CFR 110.35(c). Our investigator observed live insects and apparent fecal matter in the following processing areas:
Approximately 25 live insects, that appear to be cockroaches, were located inside your walk-in proofer box. These insects were observed crawling on the walls, ceiling, and on equipment stored inside your walk-in proofer box.
Approximately 60 piles of apparent feline fecal matter were observed inside your southern-most walk-in cooler. Although this walk-in cooler is currently not operational to provide refrigeration, your firm uses this walk-in cooler as a storage area for both decommissioned and operational processing equipment and utensils such as baking trays.
Additionally, our investigator observed the roll-up door for your main entrance lacks measures to exclude pest from your processing area when in the open position. This roll-up door was open during the entire duration of our inspection.
Your toilet facility located across from your walk-in cooler is not maintained in a sanitary condition as required by 21 CFR 110.37(d)(1). Our investigator observed toilet paper, hand soap, hand sanitizer, and an effective measure for drying hands were not available.
Your hand washing facility located across your processing work benches lack effective hand-cleaning and sanitary preparations as required by 21 CFR 110.37(e)(2). Our investigator observed soap intended for hand cleaning and towel services, or suitable drying device, were not available.
The violations cited in this letter are not meant to be an all-inclusive list of violations in your facility. It is your responsibility to ensure that your firm complies with the Act and its implementing regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products, injunction, and/or prosecution.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the time within which you will complete the corrections.
Your response should be sent to U.S. Food and Drug Administration at the following address:
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions with regard to this letter, please feel free to contact Compliance Officer William V. Millar at (510) 337-6896 or email firstname.lastname@example.org.