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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Jensen & Pilegard 17-Mar-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Say Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700




VIA FEDERAL EXPRESS

Our Reference: 2911068

March 17, 2006

Donald R. Pilegard
President
Jensen & Pilegard
1668 G Street
Fresno, CA 93706-3318

WARNING LETTER

Dear Mr. Pilegard:

An investigation of your licensed medicated feed mill conducted by Food & Drug Administration investigators on November 14, 15 and 16, 2005, found significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21 Code of Federal Regulations, Part 225 (21 C.F.R. 225). Such deviations cause 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, our investigation revealed deviations from labeling requirements that cause the medicated feeds manufactured by your facility to be misbranded under' section 502(f)(1) [21 U.S.C. § 352(f)(1)] of the Act. The deviations for the label requirements also cause the medicated feed to be unsafe under section 512(a)(2)(i) [21 U.S.C. § 360b(a)(2)(i)] of the Act and therefore adulterated under section 501(a)(6) [21 U. S.C. § 351(a)(6)] of the Act.

Our investigation found the following deviations from cGMP requirements:

1. Failure to have adequate cleanout procedures for all equipment used in the manufacture and distribution of medicated feeds to avoid unsafe contamination of feed with drugs [21 C.F.R. 225.65]. Specifically, our review of your production records and mixer schedules found that batches of medicated feed containing a specific drug are followed by the production of another medicated feed containing a different drug and batches of non-medicated feed are produced following the production of a medicated feed with no indication that procedures are utilized to avoid unsafe contamination of feeds with drugs.

2. Failure to maintain a Master Record File [21 C.F.R. 225.102] which includes the correct name of each drug ingredient to be used in the manufacture of the medicated feed. The formula for Poultry Feed [redacted] indicates the drug [redacted] as the single active drug ingredient, however, on 8/30/05 and 9/2/05 you used the drug [redacted] instead of [redacted]. In addition, on 8/16/05, in Poultry Feed [redacted] you used the drug [redacted] instead of [redacted]. In addition, the Master Record File has not been prepared, checked, dated, and signed or initialed by a qualified person [21 C.F.R. 225.102(b)(4)]

3. Failure to maintain a Master Record File [21 C.F.R. 225.102(b)(1)(iii)] which includes a copy or description of the label or labeling that will accompany the medicated feed.

4. Failure to accurately test ail scales used in the manufacture of medicated feeds at least once per year [21 C.F.R. 225.30(b)(4)], or more frequently as may be necessary to insure their accuracy. During our investigation, there were no records documenting any testing on your [redacted] scale used in the, manufacture of medicated feeds by your firm.

5. Failure to have suitable construction to minimize access by rodents, birds, insects, and other pests, to maintain the building in a reasonably clean and orderly manner, and to maintain building grounds so that they are reasonably free from waste and refuse [21 C.F.R. 225.20]. Our investigation noted holes in feed storage bins (causing feed to be spilled on the floor) and silos. Our investigators noted a dead bird, rodent, and waste in the receiving and load out areas.

Your medicated feeds are misbranded under section 502(f) [21 U.S.C. § 352(f)] of the Act due to your practice of using a page from the Feed Additive Compendium as labeling. This practice does not provide sufficient information to allow the purchaser of the medicated feed to use the feed in a safe manner. For example, the Feed Additive Compendium page for monensin does not advise the purchaser of the actual final level of the drug in the feed they purchased. The information you provided gives a range of drug level from 90 to 110 grams per ton. The information you provide also does not advise the purchaser as to whether the feed is intended to be fed to broiler chickens or to replacements intended for use as caged layers. In addition, the information provided does not advise the user as to how and what level to feed product. This labeling does not provide adequate directions for use and causes these feeds to be misbranded under section 502(f)(1) [2I U.S.C. § 352(f)(1)] of the Act. The deviations from the approved labeling also cause 'these feeds containing drugs to be unsafe under section 5l 2(a)(2)(A)(i) [21 U.S.C. § 360b(a)(2)(A)(i)] of the Act and therefore, adulterated under 501(a)(6) [21 U.S.C. § 351(a)(6)] of the Act.

In addition to the above mentioned violations we have serious concerns over your drug inventory and reconciliation practices [21 C.F.R. 225.42(b)(7)]. Specifically, we are concerned with your practice of rounding drug usage amounts up or, down to simplify calculations and your failure to take corrective action to reconcile dug discrepancies and accurately weigh drug ingredients. Please note that 21 C.F.R. 225 .42(b)(7) requires that drug inventory be maintained by means of a daily comparison of the actual amount of drug used with the theoretical drug usage. You are required to investigate any significant discrepancy and take corrective action.

The above is not intended as an all-inclusive list of cGMP and other violations found at your facility. 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.

We conducted cGMP inspections of your facility on January 16-18, 2001, April 11-15 2003, and again on February 17-22, 2005, and we noted the same or similar violative conditions during these inspections. 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) [21 U.S.C. § 360(m)(4)(B)(ii)] of the Act and 21 C.F.R. 515.22(c)(2). This letter constitutes official notification under the law.

Based on the results of the November 14, 15, and 16, 2005, investigation, 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 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 reply should be directed to Karen L. Robles, Consumer Safety Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, you may contact Karen Robles at (916) 930-3674 ext 14.

Sincerely,

/S/

Barbara J. Cassens
District Director
San Francisco District