Mr. Lam Chan
- P & L Distributor Inc. DBA Asia World Food Wholesale Company
3573 S 1950 W
West Valley, UT 84119
- Issuing Office:
- Denver District Office
| || |
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 25, 2016
VIA UPS Overnight Delivery
Mr. Lam Chan, Owner
P & L Distributor Inc. DBA Asia World Food Wholesale Company
3575 S 1950 W
West Valley City, UT 84119-3851
Dear Mr. Chan:
On November 19 – 24, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 3575 S 1950 W, West Valley City, Utah. The inspection found that you have serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) in the Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations Part 110 (21 CFR 110). These conditions cause the products being held 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 food products 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 FDA regulations through links on FDA’s home page at http://www.fda.gov
We have reviewed your undated response received on December 14, 2015 and a second response dated January 25, 2016 submitted in response to the Form FDA-483, Inspectional Observations, (FDA-483) issued to you at the close of the inspection. A copy of the FDA-483 is included for your reference.
The specific cGMP violations observed during the inspection include, but are not limited to, the following:
1. Buildings and Facilities: Sanitary Operations (21 CFR 110.35)
a. You failed to maintain your building, fixtures, and other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). For example, spilled powders and liquids and loose, degrading food were observed throughout the facility. Damaged, torn containers exposed food products to the environment. In addition, the overall organization and storage of food products prevented adequate cleaning.
b. You failed to take effective measures to exclude pests from the storage areas in your facility as required by 21 CFR 110.35(c). Specifically, we identified evidence of bird and insect activity throughout your facility including bird feces and dead mite-like, spider-like, and worm-like insects.
2. Buildings and Facilities: Plant and Grounds (21 CFR 110.20)
a. You failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, a man door was observed open and unattended for approximately two hours during the inspection and gaps were observed between doors and wall junctures of the loading dock door and west side glass doors.
We have reviewed your responses including the submitted photographs. Although your responses indicate that corrective actions have been taken to address the observations from the November 2015 inspection, we cannot determine the adequacy of the corrections because you did not include information on how the corrections will be maintained on an on-going basis. The issue of maintaining appropriate sanitation throughout your facility was also discussed during a Regulatory Meeting held with you via telephone, at the FDA Salt Lake City Resident Post, in April 2015 following your previous violative inspection. The observations noted during the November 2015 inspection were repeat observations from the July 2013 and January 2015 inspections indicating that a sound sanitation program has not been implemented and/or followed at your facility.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction or prosecution.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s 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.
Within 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. You should include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete a corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your written response should be directed to the U.S. Food and Drug Administration, Attention: Hanna L. Potter, Compliance Officer, at the above address. If you have questions about this letter, please contact Ms. Potter at (303) 236-3094.
LaTonya M. Mitchell
Denver District Director
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