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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Kamawi, Inc. 11/15/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
         FAX: (410) 779-5707

 

**WARNING LETTER**
CMS# 377580

November 15, 2012

Certified Mail
Return Receipt Requested

Mr. Karim A. Nazary, Owner
Kamawi, Inc.
8532 Terminal Rd.; Suite Q
Lorton, VA  22079-1428

Dear Mr. Nazary:

We inspected your firm, a manufacturer of ready-to-eat (RTE) flatbreads and other Afghan foods, located at 8532 Q Terminal Road, Lorton, VA 22079-1428 on October 4, 10, 16, and 18, 2012.  The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).  Furthermore, two samples were collected for filth analysis during the inspection.  Laboratory evaluation of Investigational Sample 748481 confirmed the presence of bird excreta at five locations, including direct product contact surfaces, on the conveyor belt in your production area.  Laboratory evaluation of Investigational Sample 777207 confirmed the presence of rodent excreta pellets (REPs) at five locations in your warehouse area where finished product packaging is stored.  Collectively, these CGMP violations and adverse laboratory findings 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 can find the Act and its implementing regulations on FDA’s home page www.fda.gov.

Specifically, our inspection of your facility revealed the following CGMP violations:

1.) Your firm failed to take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).  There was evidence of widespread bird and rodent activity throughout your facility.  Specifically, our investigators observed the following:

a. At least three (3) birds were observed flying directly above RTE flatbreads in the processing room, and one (1) bird was observed to land directly on a RTE flatbread cooling on level two of the conveyor belt.
b. Bird excreta too numerous to count were observed on the top and side surfaces of the conveyor belts used to transport RTE flatbreads from the ovens to the packaging area.
c. One (1) bird was observed excreting its waste directly onto a permeable bag of flour located in the processing room.
d. One (1) bird was observed landing in an open bowl of flour and pecking at the flour with its beak.
e. One (1) live mouse was observed running across Suite S, which is where the Pastry Room and walk-in cooler are located.
f. REPs too numerous to count were observed on a shelf in the warehouse that also contained RTE flatbread packaging materials.

2.) Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7).  Specifically, our investigators observed the following:

a. A screen door on the southwestern wall of the processing room had a tear, approximately five (5) inches by three (3) inches.
b. Two (2) windows were partially open, approximately twelve (12) inches by four (4) inches, along the southwestern wall of the processing room.
c. The loading dock door, approximately eight (8) feet by eight (8) feet in size, was held open approximately two and one-half (2.5) hours even though it was not continuously in use.

Previous inspections of your firm, occurring March 31 through April 2, 2009 and August 12 through 15, 2011, have also cited your firm for failing to provide adequate screening or other protection against pests.

3.) Your firm failed to clean food-contact surfaces as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d).  Specifically, our investigators observed that the entire top surface of the conveyor belt, approximately 260 feet of metal bars was covered in a blackened sticky substance and apparent dust-like particles too numerous to count.

4.) Employees failed to wear hair nets where appropriate, as required by 21 CFR 110.10(b)(6).  Specifically, our investigator observed on October 4, 2012 an employee packaging RTE white and whole wheat flatbreads in the processing area while not wearing a hair net.

This same deficiency was cited during a previous inspection of your firm that took place August 12 through 15, 2011.

This letter may not list all the violations at your facility.  You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA.  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 and/or injunction.

We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter.  Your response should include the specific steps you have taken to prevent these violations from recurring.  If you can not complete this within 15 working days, state the reason for the delay and the time within which these actions will be completed.

Your response should be directed to:  Mr. Ernest F. Bizjak, Compliance Officer, U.S. Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, MD 21215.  If you have any questions, please do not hesitate to contact Mr. Bizjak by calling (410)779-5715 or sending an email to ernest.bizjak@fda.hhs.gov.

Sincerely yours,

/S/                                  
                       
Evelyn Bonnin
District Director
Baltimore District Office

 

Attached:

• Laboratory evaluation of Investigational (Filth) Sample 748481 – bird excreta
• Laboratory evaluation of Investigational (Filth) Sample 777207 – REP