Inspections, Compliance, Enforcement, and Criminal Investigations
J D Heiskell & Co 12-May-05
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
May 12, 2005
J D Heiskell & Co
P.O. Box 51493
Ontario, California 91762
Dear Mr. Anderson:
An inspection of your medicated feed mill located at 5355 E. Airport Drive, Ontario, CA, conducted December 22 through December 28, 2004, found significant deviations from the current Good Manufacturing Practice (cGMP) regulations for medicated feed manufacturers, Title 21, Code of Federal Regulations, Part 225 (21 CFR 225). Such deviations cause feeds being manufactured at your facility to be adulterated within the meaning of Sections 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). In addition, the [redacted] CALF GROWER feed you manufacture is not labeled in conformance with the approved uses of monensin, as set out in 21 CFR 558.355, which also causes it to be adulterated within the meaning of section 501(a)(6) of the Act.
Section 501(a)(2)(B) of the Act states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with cGMP to assure that such feed meets the requirements of the Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
Our investigation found that your firm's manufacturing processes did not conform to cGMP requirements. This deviation from the regulations was reported to you in the Inspectional Observations, Form FDA 483, which was issued at the conclusion of the inspection and included the following:
Failure to maintain a record of corrective action when assay results show medicated feeds are not within permissible assay limits. Specifically, you have no records to indicate that you investigated and implemented corrective action with regard to 10 monensin assays that were out of specification. [21 CFR 225.158]
In addition, further review of the documents collected during the inspection revealed that you are currently manufacturing a monensin Type C medicated feed from a Type A medicated article; this feed is not labeled in accordance with the approved uses of monensin. The approved uses of monensin are set out in 21 CFR 558.355. Specifically, the [redacted] CALF GROWER product is labeled as containing 40 grams per ton of monensiis labeled as a calf grower with the intended use, "For increased rate of weight gain." As indicated in 21 CFR 558.355 (f)(3)(iii), monensin at 25 to 400 grams per ton is approved for increased rate of weight gain when fed to "pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers)."Your product is not labeled for use in accordance with the approved use in cattle on pasture. For this reason, the [redacted] CALF GROWER product is unsafe under section 512 of the Act and and adulterated within the meaning of section 501(a)(6) of the Act.
These violations are not intended to be an all-inclusive list of deficiencies at your facility. As a producer of medicated and non-medicated feeds, you are responsible for assuring that your establishment is in compliance with all requirements of the federal regulations. We note that observations 2 through 6 in the Form FDA-483 apply to licensed feed mills. These observations do not apply to you because you are not a licensed feed mill.
We are very concerned about your firm's lack of adequate investigation of out-of specification assay results. Out-of-specification assays may be the result of any number of circumstances. It is critical that you evaluate all possible causes and determine the likely basis for the unexpected or out-of-specification result. Possible causes include, but are not limited to: age and storage of the medication, mixing time, age and quality of equipment used, scale accuracy, sampling technique, physical characteristics of the equipment and commodities, or human error. Each contributing factor should be considered when corrective action is implemented.
You should take prompt action to correct and prevent recurrence of the deviations listed. Failure to promptly correct these deviations may result in regulatory action including, but not limited to, seizure and/or injunction
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific actions 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. Please include copies of any available documentation showing that corrections have been made. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which corrections will be completed. If you have any questions or clarifications regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at (949) 608-4439.
Please direct your written response to the attention of:
Pamela B. Schweikert
Director, Compliance Branch
United States Food and Drug Administration
Irvine, CA 92612-2506
Alonza E. Cruse