|Company:||Cache Commodities, Inc.|
|Subject:||CGMP Requirement for Food Manufacturing/Adulterated|
|Issuer:||Denver District Office|
|Issued:||Jan. 13, 2006||Closed:||
Department of Health and Human Services
Public Health Service
January 13, 2006
RETURN RECEIPT REQUESTED
Mr. Ron Curtis
Cache Commodities, Inc.
860 West 24th Street
P.O. Box 387
Ogden, UT 84402-0387
Dear Mr. Curtis:
An inspection of your medicated feed mill, located at 860 West 24th Street, Ogden, Utah, conducted by the Food and Drug Administration (FDA) on September 6 - 9, 2005, revealed that your facility manufactured Type C medicated feeds from a Category 11, Type A medicated article, [redacted] on several occasions, most recently July 7, 2005. Under section 512(m)(1) [21 U.S.C. § 360b(m)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (21 CFR) Section 558.4, you cannot manufacture this feed without a FDA medicated feed mill license. Because you manufactured these feeds without a medicated feed mill license, these feeds are considered unsafe under section 512(a)(2)(B) [21 U.S.C. § 360b(a)(2)(B)] and therefore adulterated within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act.
Specifically, because your firm did not have a medicated feed mill license when you manufactured the [redacted] for [redacted] this feed is adulterated within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act.
FDA regulations at 21 CFR Part 225 set out the current good manufacturing practice (CGMP) requirements that apply to facilities manufacturing medicated feeds. Facilities manufacturing one or more medicated feeds for which an approved medicated feed mill license is required must comply with the CGMP requirements in 21 CFR § 225.10 through § 225.115. Facilities manufacturing solely medicated feeds for which an approved medicated feed mill license is not required must comply with the CGMP requirements in 21 CFR 5225.120 through § 225.202.
We acknowledge your verbal indication to the FDA investigator that you would no longer use the Category II, Type A medicated article [redacted] to manufacture [redacted] containing Type B and Type C medicated feeds. We also recognize your written submission to the FDA, Center for Veterinary Medicine, Division of Animal Feeds, dated September 13, 2005, stating, [redacted] .
[Redacted ] [ However, please note that if you use a Category 11, Type A medicated article to manufacture Type B or C medicated feeds, you must apply for, and be granted, an FDA Medicated Feed Mill License prior to manufacturing such medicated feed, and, as a licensed feed mill, you must comply with the CGMP requirements in 21 CFR § 225.10 through § 225.115.
Our investigation revealed that you no longer manufacture any medicated feeds for which a medicated feed mill license is required. Therefore, your facility is currently subject to the CGMP requirements in 21 CFR § 225.120 through § 225.202. Our investigator conducted an inspection to determine your firm's compliance with these regulations. During the inspection, our investigator noted the following deviations from CGMP requirements:
1. Failure to establish and use adequate procedures for all equipment used in the production of medicated feeds to avoid unsafe contamination of medicated and non-medicated feeds, as required by 21 CFR § 225.165. Specifically, [redacted] used to flush your equipment following the production of a batch of medicated feed is returned to the bulk [redacted] bin and could be used in the manufacture of other feeds. Use of this [redacted] in other feeds could cause the feed to be adulterated with drug residues from the [redacted] .
2. Failure to establish adequate procedures to aid in assuring the identity, strength, quality, and purity of your Type A medicated articles, as required by 21 CFR § 225.142. Under this regulation, bulk Type A medicated articles shall be identified and stored in a manner such that their identity, strength, quality, and purity will be maintained. However, you are removing bulk Type A medicated articles from their original packaging and placing them in plastic storage bins, identified only with the name of the article. The manufacturer, product lot numbers, product strength, and expiration dates were not recorded on the bulk plastic bins.
3. Your buildings and grounds are not constructed and maintained in such a manner to minimize vermin and pest infestation, as required by 21 CFR § 225.120. For example, the investigator observed animal feces next to a broken bag of feed and numerous routes of entry for pests. In addition, the investigator observed a significant amount of feed on the ground, which could attract pests.
4. Failure to maintain, on the premises, records identifying the formulation, date of mixing, and date of shipment of medicated feeds for one year following the date of last distribution, as required by 21 CFR § 225.202.
The above is not intended as an all-inclusive list of violations. As a manufacturer of medicated and non- medicated feeds, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to make immediate and lasting corrections may result in regulatory action without further notice such as seizure and/or injunction.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to achieve and maintain compliance with the law. Your response should include an explanation of each step being taken to correct the CGMP violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Your response should be directed to: Food and Drug Administration, Denver District, P. O. Box 25087, Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions, please contact Mr. Sherer at (303) 236-3051.
B. Belinda Collins