| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
August 11, 2014
WL # 30-14
Bradley C. Pope, Owner
3315 Van Buren Blvd.
Riverside, CA 92503
Dear Mr. Pope:
An inspection of your licensed medicated feed mill, Brookhurst Mill, located at 3315 Van Buren Blvd., Riverside, California conducted by the Food and Drug Administration (FDA) on March 03 through 18, 2014, documented significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations, Part 225 (21 CFR 225). Such deviations cause medicated feed manufactured at this facility to be adulterated within the section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov
In addition, our inspection determined that you manufactured and distributed a medicated feed, Gamebird Grow, that is misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)], adulterated under section 501(a)(6) [21 U.S.C. § 351(a)(6)]of the Act, and contains a new animal drug that is adulterated under 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. First, the medicated feed is misbranded under 403(a)(1) [21 U.S.C. 343(a)(1)] because it contained amprolium at levels less than what was indicated on the product label. The labeling states it contains 0.025% amprolium, however testing revealed it only contains 0.014% amprolium. Accordingly, the labeling was false and misleading.
In addition, the name of your medicated feed “Gamebird Grow” indicates it is being sold for use in game birds. Amprolium is not approved for game birds other than pheasants, and is only approved for pheasants in the amount of 0.0175%. (21 CFR 558.55) But your medicated feed is labeled as having 0.025% amprolium--a level of amprolium inclusion only approved for use in laying, broiler and replacement chickens, or turkeys for the prevention or treatment of coccidiosis (21 CFR 558.55) and testing revealed it only contains 0.014% amprolium. Therefore, the new animal drug contained in the feed (amprolium) is unsafe within the meaning of § 512(a)(1)(A) [21 U.S.C. 360b(a)(1)(A)] of the Act because the drug was not used in conformance with the drug approval. As a result, the new animal drug is adulterated under 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. In addition, the animal feed containing the new animal drug is unsafe under 512(a)(2)(A)(i) [21 U.S.C. § 360b(a)(2)(A)(i)] of the Act because the use and/or labeling of this animal feed does not conform with the approval for the drug. As a result, the animal feed containing the new animal drug is adulterated under 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act.
Our investigation also found significant cGMP deviations including, but not limited to, the following:
1. Failure to implement corrective action when assay results show medicated feeds not in accord with label specifications and not within permissible assay results as required by [21 CFR 225.58(d)]. Our inspection found that your firm did not implement corrective actions on 13 assays when results were not within permissible limits since April of 2009. For example:
Your firm failed to determine and correct the cause where results of assays indicate the medicated feed is not in accord with label specifications or is not within permissible assay limits. Your firm manufactured on 1/7/2014, and distributed on 1/8/2014, a product called Gamebird Grow formulated and labeled to contain a concentration of 0.025% Amprolium. Your February 2014 periodic assay of medicated feed for Amprolium was conducted on the production batch, and the assay result was 0.014% Amprolium. A firm representative stated in an affidavit that he thinks that the low assay results are occurring because when your firm adds the flush material back to the feed, the assay results are negatively affected. Your firm has not conducted further investigation to confirm that theory, or initiated corrective action to address the suspected problem. Investigation and corrective actions shall be implemented and an original or copy of the record of such action maintained on the premise.
2. Failure to discontinue distribution of medicated feed until proper control procedures were established as part of the corrective action for medicated feed which failed to meet its labeled drug potency as required by [21 CFR 225.58(e)]. Our inspection found corrective actions were not implemented by your firm, and you continued to manufacture and distribute medicated feed after it failed to meet labeled drug potency requirements. Distribution of subsequent production of a particular feed shall not begin until it has been determined that proper control procedures have been established. For example:
Your firm manufactured and distributed a minimum of 24 batches of medicated feed containing Amprol 25% after receiving out-of-limits assay results in April 2009. A firm representative stated in an affidavit that your firm has not implemented corrective actions after receiving the out-of-limit assay results. Your firm records at the time of the inspection indicated that you last distributed medicated feed on 1/08/2014 and manufactured an additional medicated feed as recently as 1/13/2014, and did not implement control procedures.
3. The Master Record File does not contain manufacturing instructions or reference thereto that have been determined to yield a properly mixed medicated feed of the specified formula for each medicated feed produced and appropriate control directions including the collection of samples for specified laboratory assays as required by [21 CFR 225.102(b)(1)(iv)], [21 CFR 225.102 (b)(1)(v)]. Our inspection found that in your production of medicated feed, you failed to follow manufacturing instructions or reference thereto that have been determined to yield a properly mixed medicated feed of the specified formula. For example:
Your Master Record File for Type-A medicated finished feeds did not contain the manufacturing instructions. The master record file documents only indicate the ingredient formulation and actual amount of ingredient added; however, these instructions do not contain mixing steps, mixing times or sampling procedures. In addition, the manufacturing instructions do not yield a properly mixed medicated feed of the specified formula as evidenced by 13 out-of-specification assay results for this product since 2009.
Your firm is required by [21 CFR 510.301(a)(2)] to immediately, upon receipt by applicant, submit complete records or reports covering information of any failure of one or more distributed batches of the drug which do not meet the specifications established for it, in the new animal drug application; for which an approved medicated feed mill license is in effect. Such failure should be reported to FDA, Center for Veterinary Medicine, Medicated Feeds Team (HFV-226), Room E431, 7519 Standish Place, Rockville, MD 20855. However, your firm has not submitted the drug assay failure report to FDA to date.
The above is not intended as an all-inclusive list of deficiencies of your facility. As a licensed manufacturer of medicated feeds, you are responsible for assuring your overall operation and the products you manufacture and distribute are in compliance with the Act and its implementing regulations.
Your firm representative stated in a signed affidavit that your firm will no longer manufacture this product. If your firm does continue to manufacture this product, you should take prompt action to correct the noted violations and establish procedures so these violations do not recur. Failure to promptly correct these cGMP violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction and/or notice of opportunity for a hearing on a proposal to withdraw approval of your Medicated Feed Mill License under section 512(m)(4)(B)(ii) [21 U.S.C. 360b(m)(4)(B)(ii)] of the Act, and 21 CFR 515.22(c)(2).
Based on the results of the March 2014 inspection, evaluated together with the evidence before FDA when the Medicated Feed License was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drug therein. This letter constitutes official notification under the law and provides you an opportunity to correct the deficiencies in your operations.
You should notify this office, in writing, within fifteen (15) working days of receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step being taken to correct the violations, and prevent their recurrence. If corrective actions cannot be completed in 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 firm’s response should be sent to:
Acting Director of Compliance
Attention: Dr. Raymond W. Brullo, Compliance Officer
Compliance Branch, Food and Drug Administration
Irvine, CA 92612
If you have any questions about the content of this letter please contact: Dr. Raymond W. Brullo at (949) 608-2918. Refer to the unique identification number, FEI # 2011163, when replying.
Mr. Alonza E. Cruse, Director
Los Angeles District
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence
Annette Jones, DVM
California Department of Food and Agriculture
1220 N Street
Sacramento, California, U.S.A. 95814