|Company:||International Nutrition, Inc.|
|Subject:||CGMP Regulations for Food/Adulterated|
|Issuer:||Kansas City District Office|
|Issued:||Feb. 7, 2006||Closed:||
Department of Health and Human Services
Public Health Service
Kansas City District
February 7, 2006
RETURN RECEIPT REQUESTED
Ref. KAN 2006-12
Steven J. Silver
International Nutrition, Inc.
P.O. Box 27540
Omaha, NB 68127-0540
Dear Mr . Silver:
An investigation of your medicated feed mill and drug manufacturing site, located at 4444 South 76thCircle, Omaha, Nebraska conducted by a Food and Drug Administration (FDA) investigator between July 26, 2005 and August 10, 2005 found a significant deviation from the Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations (CFR), Part 225 (21 CFR 225) . Such a deviation causes the feeds being manufactured at this facility to be adulterated within the meaning of section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act). In addition, several labeling deviations were observed that cause certain feed products manufactured by your firm to be adulterated within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act. Also, the distribution of Type A medicated articles to consignees without receipt of an unrevoked written statement from the consignees in accordance with section 512(a)(1) [21 U.S. C.§ 360b(a)(1)] caused the new animal drug to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.
Our investigation found that your firm failed to implement adequate safeguards to prevent unsafe contamination in the production of feeds [21 CFR 225.65(b)].
A calf vitamin/mineral product was manufactured following the production of a Category II, Type B medicated feed Carbadox (Mecadox 2.5, lot #5-201-5476). An analysis of FDA sample 340165 found 170 and 25 ppm in two of the ten subs collected during the investigation. Carbadox is not approved for use in cattle feed."
On September 10, 2004 Arsanilic Acid 4.5g/lb, lot 4-232-9970, was manufactured by sequencing after ProGen 20% (arsanilic acid 90g/lb). Assay of Arsanilic Acid 4.5g/Ib, lot 4-232-9970, found it to be 131 % which is outside of the allowable assay limits of 85-115 %. The investigation into the cause of the out-of-limits assay, dated September 15, 2004, concluded carryover from production of the ProGen 20% was a likely cause.
Our investigation also found that your firm distributed Type A medicated articles to consignees from whom the firm did not obtain an unrevoked written statement in accordance with section 512(a)(1) [21 U.S.C. § 360b(a)(1)] of the Act. Such action causes the new animal drug to be deemed unsafe under section 512(a)(1) [21 U.S.C. § 360b(a)(1)] and thus adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.
The FDA investigator observed labeling deviations that cause certain feed products to be misbranded foods under section 403(a)(1) [21 U.S.C. § 342(a)(1)] of the Act.
Product labels for ZINPRO Corporation products containing the statement "Manufactured By ZINPRO Corporation" when the products are manufactured by International Nutrition Inc. for ZINPRO Corporation. This is a deviation from the labeling requirements found in 21 CFR 501.5(c).
In addition, our investigation found that labels for your feeds containing procaine penicillin and decoquinate, for use in poultry laying hens and sheep respectively, are not in conformance with the approved new animal drug applications. The approval for procaine penicillin provides that feed be labeled with a warning against use in poultry laying eggs for human consumption. The approval for decoquinate provides that feed be labeled with a warning against use in sheep producing milk for food. Labeling these products without the required warning statements causes these feeds to be unsafe under section 512(a)(2) [21 U.S.C. §360b(a)(2)] of the Act, and thus adulterated within the meaning of section 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act.
We have also determined that your firm has not maintained in its possession copies of the New Animal Drug Application approved labels as required by 21 CFR 510.305. This lack of record keeping causes your firm to be out of compliance with section 512(m)(5)(A) [21 U.S.C. § 360b(m)(5)(A)] of the Act.
The above is not intended as an all-inclusive list of violations. As a manufacturer of Category II, Type A medicated articles and 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 Act and its implementing regulations.
You should take prompt action to correct these violations and prevent their recurrence. Failure to achieve prompt corrective action may result in regulatory action without further notice, such as seizure and/or injunction.
We are in receipt of responses from your firm dated October 21, 2005 and October 25, 2005, signed by Reid S. Adkins, Ph.D. Although it appears from your response that you are working toward correcting the deviations noted at your firm, you must adequately implement and maintain each corrective action to ensure its effectiveness. Your response is being reviewed and a reply will be sent in a separate letter.
You should notify this office within fifteen (15) working days of receiving 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, labeling, and other violations noted in this letter. If corrective action cannot be completed within 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.
Please send your response to Joseph G. Kramer, Compliance Officer, at the above address.
John W. Thorsky
Kansas City District