| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 13 ,2010
W/L 15-10
Shirlee K. Jelwin, President, and
Thomas E. Jermin, Jr., Vice President
Templeton Feed & Grain Inc.
405 S. Main Street
Templeton, California 93465-5302
Dear Mrs. Jermin and Mr. Jermin:
An investigation of your medicated feed mill located at 405 S. Main St., Templeton, California, conducted by a Food and Drug Administration investigator from November 3-6, 2009, found significant deviations from Current Good Manufacturing Practice (cGMP) regulations for Medicated Feed (Title 21 Code of Federal Regulations, Part 225). Such deviations cause feed being manufactured at this facility to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) 21 U.S.C. 351 (a)(2)(B). Furthermore, this inspection documented the use of a Type A medicated article, containing the drug sulfamethazine, contrary to its new animal drug application (NADA), NADA 035-688. When sulfamethazine was used in animal feed labeled as containing sulfathiazole, this drug and the animal feed containing the drug were deemed to be unsafe within the meaning of section 512(a)(1)(A) and (a)(2)(A) of the Act, U.S.C. § 360b(a)(a)(1)(A) and (a)(2)(A), and adulterated within the meaning of section 501(a)(5) and (a)(6) of the Act, 21 U.S.C. § 351(a)(5) and (a)(6), as well as, misbranded within the meaning of section 403(a) of the Act, 21 U.S.C. § 343(a).
Our investigation found:
1. Your firm did not perform periodic assays for each drug or drug combination used during the calendar year on at least three representative samples of medicated feeds requiring a medicated feed mill license, 21 C.F.R. 225.58(b)(1). You were notified of this deficiency during a previous inspection and in the Warning Letter issued to your firm on March 22, 2000.
During 2009, you manufactured three four-ton lots of Pig Starter & Grow Medicated Feed with CSP-500 Type A medicated article (lot 10, dated 3/12/09, lot 11, dated 4/15/09, lot 12, dated 5/6/09). You neither have documentation showing one sample from each of these three lots was submitted for assay, nor do you have any records of assay results.
2. There is no evidence that you conducted an investigation or took corrective action when assay results revealed medicated feed did not meet drug concentration specifications. You not only are required to conduct an investigation and take corrective action, but are also required to maintain an original or copy of action taken as directed in 21 C.F.R. 225.58(d). You were notified of this deficiency during a previous inspection and in the Warning Letter issued to your firm on March 22, 2000.
The State of California Department of Food and Agriculture assay results for Pig Starter & Grow Medicated Feed lot number 4, dated 11/6/2007, document the amount of sulfathiazole as 45.4 grams per ton. The minimum labeled amount of sulfathiazole is 100 grams per ton. There are no records documenting an investigation to determine the reason for the out-of-specification result and there are no records documenting corrective actions taken.
3. Your firm failed to have adequate procedures established for the inventory control of all drugs to aid in assuring their identity, strength, quality, and purity when incorporated into products, in violation of 21 C.F.R. 225.42(b). You were notified of this deficiency in your procedures during a previous inspection and in the Warning letter issued to your firm on March 22, 2000.
The current investigation revealed that there was one open package containing ten pounds of CSP-500 Type A medicated article (lot number AB00709-1, Expiration January 09) in the plastic storage bin in the medication storage and weighing room. The lot was not entered in the inventory/receipt log.
Inventory/receipt logs document that 100 pounds of CSP-500 Type A medicated article (lot number XB00L517-4) was received on 7/26/06, but no expiration date was entered in the log. One hundred pounds was in inventory.
4. Your firm failed to identify incoming Type A medicated articles to ensure the safety and effectiveness of the medicated feed produced, in violation of 21 C.F.R. 225.42(b)(1).
5. Your firm received into inventory a Type A Medicated Article, CSP-500, containing the new animal drug sulfamethazine. Your firm mistakenly used that product in feed labeled as containing sulfathiazole. The resulting Pig Starter & Grow Medicated feed containing sulfamethazine caused the drug and animal feed containing the drug to be adulterated within the meaning of section 512(a) of the Act, adulterated within the meaning section 501(a)(5) and (a)(6) of the Act, 21 U.S.C. 351(a)(5) and (a)(6) and misbranded within the meaning of section 403(a) of the Act, 21 U.S.C. 343(a).
Feed containing the drug sulfamethazine requires the cautionary label statement ''withdraw 15 days prior to slaughter." The Pig Starter & Grow Medicated Feed was labeled with the wrong statement, "Warning: withdraw 7 days prior to slaughter. As a result, the labeling was false or misleading.
The above is not intended as an all-inclusive list of cGMP violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct these cGMP violations, and you should establish procedures whereby such 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) of the Act, 21 U.S.C. 360b(m)(4)(B)(ii) and 21 C.F.R. 515.22(c)(2). (This letter constitutes official notification under the law.) Based on the results of the November 2009 inspection, evaluated together with the evidence before FDA when the Medicated Feed Mill 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 drugs therein. >This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
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 bring your firm into 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 30 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 written reply should be directed to:
Dan Cline
Acting Director Compliance Branch
Los Angeles District
U. S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612
If you have any questions regarding this letter, please contact Mr. John Stamp, Compliance Officer at 949-608-4464.
Sincerely,
/s/
Alonza E. Cruse
District Director
Los Angeles
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