Inspections, Compliance, Enforcement, and Criminal Investigations
Pendelton Flour Mills, LLC 20-Sep-01
DEPARTM ENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
September 20, 2001
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 01-88
Anthony Flagg, President
Pendleton Flour Mills, LLC
501 SE Emigrant .Avenue
Pendleton, Oregon 97801
Dear Mr. Flagg:
The Food and Drug Administration (FDA) conducted an inspection of your flour mill located at 3225 16th Avenue SW, Seattle, Washington, on August 22, 24 and 29, 2001. The inspection revealed numerous deviations from the Good Manufacturing Practice (GMP) regulations, Title 21, Code of Federal Regulations (21 CFR) Part 110. At the conclusion of the inspection, you were issued a Form FDA-483 (copy enclosed) which delineated a number of gross insanitary conditions present in your flour mill at the time of the inspection. These conditions cause the food products to be adulterated within the meaning of Section 402(a)(4), (copy enclosed) of the Federal Food, Drug, and Cosmetic Act (the Act), in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find this Act through links in FDA?s homepage at www.fda.gov
The following is a list of the insanitary conditions observed by our investigators during the inspection:
1. Evidence of insect activity on a flour packaging system auger in the packaging warehouse. This auger had entry points that could allow insects ready access to contaminate finished product moving through the system (please refer to FDA form 483 Items # 1 a).
2. Evidence of insect activity on virtually every level of the Stack Mill along with evidence of recent rodent activity, as evidence by footprints in various locations in the plant, and by rodent excreta pellets (please refer to FDA form 483 Items # 1 b through p),
3. Areas were not maintained in a sanitary condition as evidenced by the extensive insect activity throughout the plant, and by flour residue accumulations which had live and dead insects and insect trails. The fourth floor sieve storage room appeared to be in a general state of disarray with stacks of flour residue covered screens and other miscellaneous items that provide pest harborage and breeding areas (please refer to FDA form 483 items 2 a through g).
4. Raw Materials, product lines and or equipment were not stored in a manner so as to protect them from contamination between uses as evidence by:
a. Augurs containing product were not covered while and overhead blow-down cleaning was in progress on the fifth floor of ?H? warehouse.
b. Containers of enrichments were not sealed during overhead blow-down cleaning in progress on the fifth floor of "H" warehouse.
c. Sieves/screens for the number 6-5 mill purifier were stored directly on the floor while the purifier was down for maintenance.
5. Areas of the facility were observed to be in various states of disrepair which included half-inch cracks in floors at the floor-wall junction, water leaking from the ceiling onto the sixth floor of the 4/5 mill, windows and doors not screened to protect against insect entry.
6. Lights in the processing/production areas were not shielded to protect against glass contamination of product.
Our inspection has revealed that you have a serious pest infestation problem in your plant. It is your responsibility to have an effective, ongoing sanitation program that eliminates the insanitary conditions we have observed.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. Other violations can subject the food to legal action. It is your responsibility to assure that all of your products are in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct ail of the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
We received John Whalen?s, Seattle Division Manager, letter dated September 4, 2001, written in response to the FDA Form -$83 presented to your firm at the conclusion of the inspection. Although the response adequately addresses the specific observations it did not address changes in the sanitation program, which would be designed to prevent a reoccurrence of the types of violations noted. If you had a sanitation plan in place at the time of the inspection it was either not being followed or was inadequate to prevent the violations noted.
Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Mr. Williamson, Compliance Officer at (425) 483-4976 or via e-mail at BWilliam@ora.fda. gov.Sincerely,
Charles M. Breen