United Prosperity Group DBA The Produce Company 10/13/11
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor bay Parkway
Alameda, CA 94502
Via Overnight Mail
October 13, 2011
Mr. Frederick Tsang, President/CEO
United Prosperity Group dba The Produce Company
60 Airport Blvd.
South San Francisco, CA 94080
Dear Mr. Tsang,
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food processing and storage facility located at 60 Airport Boulevard, South San Francisco, California, on June 29th, July 1st, 7th, and 8th, 2011. During the inspection, FDA investigators found serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human foods (21 CFR Part 110). These violations cause the food processed and stored 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 the 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 may find the Act and its implementing regulations through links on FDA home page at www.fda.gov.
The following significant violations were observed during the inspection of your firm:
1. You failed to take effective measures to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on June 29, 2011, two pigeons were observed in your dry goods warehouse, perched above 50 lb. mesh bags of potatoes. In addition, on July 1, 2011, our investigators observed approximately 10 bird excreta on four mesh bags of potatoes.
We acknowledge that on July 1, 2011, your firm voluntarily destroyed the pallet of potatoes that included the potatoes on which the two pigeons were observed perching, as well as the potatoes found to be contaminated with bird excreta. However, this corrective action did not sufficiently address the underlying violation.
2. You failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, on June 29, 2011, our investigators observed that the opened roll-up door to your dry good warehouse lacked appropriate screening. The plastic skirts used for screening had gaps of approximately 1 foot, allowing pigeons to enter your dry goods warehouse.
3. You failed to remove litter and waste within the immediate vicinity of the plant buildings that may constitute an attractant, breeding place, or harborage area for pests, as required by 21 CFR 110.20(a)(1). Specifically, on June 29, 2011, our investigators observed that your compost dumpster---located approximately 100 feet from your opened dry goods warehouse roll-up door---was an attractant of birds. The investigators observed pigeons on the dumpster as well as on the roof of the firm’s facility next to the dumpster. On July 1, 2011, our investigators observed that the compost dumpster was moved to approximately 10 feet from the opened dry goods warehouse roll-up door, and the birds were still present. In addition, our investigators observed that the dumpster was routinely left uncovered.
On July 7, 2011, your firm installed a simulated owl and large yellow balls on the exterior of your facility in order to control the bird problem. However, even after the simulated owl and large yellow balls were installed, our investigators continued to observe pigeons flying in and out of the compost dumpster. Our investigators also observed pigeons flying near and above the large yellow balls.
The above violations are not meant to be an all-inclusive list of the violations at your facility. You are responsible for ensuring that your products are in compliance with the applicable statutes and regulations enforced by FDA. You should take prompt action to correct these violations. Failure to promptly correct them may result in regulatory action, including seizure and/or injunction, without further notice.
Please respond in writing within fifteen (15) working days of your receipt of this letter. Your response should include each step taken or that will be taken to correct these violations and prevent recurrence. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for the delay and state when you will correct any remaining violations.
Your response should be directed to Darlene Almogela, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions about this letter, please contact Brandon L. Bridgman, Compliance Officer, at 510-337-6794.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration