Inspections, Compliance, Enforcement, and Criminal Investigations
Kim's Bean Sprouts 03-Jan-03
22201 23rd Drive SE
Bothell, WA 98021-4421
January 3, 2003CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 03-10
Jay K. Kim, Owner
Kim?s Bean Sprouts
3122 E. 112th Street
Tacoma, Washington 98446
Dear Mr. Kim:
The Food and Drug Administration (FDA) conducted an inspection of your bean sprout manufacturing plant and warehouse located at 3 122 E. 1 12th Street, Tacoma, Washington, on October 17, 18, 21, & 22, 2002. The inspection revealed numerous deviations from the Good Manufacturing Practice (GMP) regulations, Title 2 1, 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 plant at the time of the inspection. These conditions cause the food products stored in your facility 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. Rodent activity in the warehouse:
a. Rodent excreta and rodent urine stains were found on a lot of approximately [redacted] kilogram paper bags of Cor Soy Bean seeds, identified as lot #CS 17, stored in the dry storage room. Several rodent excreta pellets were found on thirteen bags, and urine stains were found on one bag.
b. Rodent excreta and urine stains were found on a lot of approximate [redacted] kilogram paper bags of [redacted] seeds, identified as lot HS2, s he dry
b. Rodent excreta and urine stains were found on a lot of approximately [redacted] kilogram paper bags of [redacted] seeds, identified as lot HS2, stored dry storage room. Several rodent excreta pellets were found on six bags, and urine stains were found on three bags,
2. Poor employee practices:
a. Trash cans used to transport your sprouts from the washing tank to the staging table are not properly stored. You currently store them directly on a dirty floor and nesting inside one another.
b. The screen used to remove sprouts from the washing tubs is stored directly on the floor when not being used. The screen is not cleaned or sanitized, and the floor is covered with water and debris.
c. An employee was observed picking up garbage from the floor, and pushing water down the staging table holding finished product without washing her hands.
d. A hose used for washing hands is stored on the floor when not being used.
3. Structural deficiencies
a. The staging table used for packing the finished product is in such disrepair making cleaning and sanitizing difficult.
Our inspection has revealed that you have a significant sanitation problem in your facility. 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 all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
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: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa Elrand, Compliance Officer at (425) 483-4913 or via e-mail at email@example.com.
Russell W. Gripp for Charles M. Breen