- Gator Feed Company
- Issuing Office:
- Florida District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700 Fax: 407-475-4770
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
January 14, 2016
Mr. Thomas W. Ziglar, President
Gator Feed Company, Inc.
Mailing Address: Physical Address:
P.O. Box 756 1205 US Highway 98 North
Okeechobee, FL 34973 Okeechobee, FL 34973
Dear Mr. Ziglar:
A comprehensive inspection of your medicated feed manufacturing facility located at 1205 US Highway 98 North in Okeechobee, Florida, was conducted by an Investigator from the U. S. Food and Drug Administration (FDA) on August 17 – 20, 2015. This inspection 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 the medicated feed manufactured at your facility to be adulterated within the section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 351(a)(2)(B)].
Certain medicated feed manufactured at your facility are also misbranded under section 502(f)(1) of the Act, [21 U.S.C. § 352(f)(1)], because their labeling lacks adequate directions for use. This is discussed further below. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov
The violations observed during the inspection include, but are not limited to, the following:
1. Failure to perform assays for medicated feeds as required by 21 CFR 225.58(b)(1). For feeds requiring a medicated feed mill license for their manufacturing and marketing, at least (b)(4) representative samples of medicated feed containing each drug or drug combination used in the establishment shall be collected and assayed by approved official methods, at periodic intervals during the calendar year. At least one of these assays shall be performed on the first batch using the drug.
Our inspection found that your firm failed to perform the required assays for feeds containing Aureo S 700, a Category II, Type A Medicated Article. For example:
a) The first batch of Bulk Custom Formula Oxer Medicated Feed containing Aureo S 700 was manufactured on March 27, 2014. Your firm did not perform a drug assay on the first batch of feed containing this drug or any subsequent batches manufactured during calendar year 2014.
b) The first batch of Bulk Wean AS-700 medicated feed containing Aureo S 700 was manufactured on January 8, 2015. Your firm failed to perform a drug assay on the first batch of feed containing this drug or any subsequent batch manufactured up to the start of this inspection.
2. Failure to maintain a complete and accurate Master Record File as required by 21 CFR 225.102(b)(1). For example, your Master Record File for your Gator Preconditioning Weaning N Medicated feed and for your Bulk 16% Yearling Medicated feed were deficient as follows:
a) The Master Record Files do not have manufacturing instructions for the Gator Preconditioning Weaning N Medicated feed or Bulk 16% Yearling Medicated feed [21 CFR 225.102(b)(1)(iv)].
b) The Master Record Files do not have control instructions for the for the Gator Preconditioning Weaning N Medicated feed or Bulk 16% Yearling Medicated feed sampling procedures regarding the manner and frequency of sample collections [21 CFR 225.102(b)(1)(v)].
c) The Master Record Files for the Gator Preconditioning Weaning N Medicated feed or Bulk 16% Yearling Medicated feed are not signed or initialed. The Master Record Files are required to be signed or initialed by a qualified person [21 CFR 225.102(b)(1)].
3. Failure to initial and date proofread labels as a record of having been proofread against the Master Record File to verify suitability and accuracy, as required by 21 CFR 225.80(b)(2). For example, product labels for your Gator Preconditioning Weaning N Medicated feeds (both chlortetracycline/sulfamethazine and chlortetracycline only) and for Bulk 16% Yearling Medicated feed have not been initialed and dated by a responsible individual.
4. Failure to use appropriate labeling that provides the user with directions for use which, if adhered to, will assure that the medicated feeds are safe and effective for their intended purposes, as required by 21 CFR 225.80(a).
a) In order to assure that the medicated feeds are safe and effective for their intended purposes, appropriate labeling that provides the user with directions for use must include feeding directions so that the animals receive the drug at the approved rate in the medicated feed. Conditions of safe and effective use of an approved combination of Chlortetracycline and Sulfamethazine in beef cattle are specified in 21 CFR 558.140(d)(1). The approval specifies the feed should provide 350 mg per head per day for each of the drugs, chlortetracycline and sulfamethazine, when use in this combination medicated feed for beef cattle.
- The label for the medicated feed "Yearling 16%" does not include feeding directions such as how and at what rate to feed the medicated feed to cattle.
- The feeding rate and concentration for Gator Preconditioning Weaning N Medicated feed and CF Oxer medicated feed does not yield 350mg/head/day. The labels for these medicated feeds say to feed at a rate of 6 lbs/head/day and the concentration of each drug in the feed is 35 gm/ton.
b) In order to assure that the medicated feeds are safe and effective for their intended purposes, appropriate labeling that provides the user with directions for use must include information on the limitations of the approval.
- The labels for the medicated feeds "Yearling 16%", Gator Preconditioning Weaning N, and CF Oxer do not include the limitation in the approval that the medicated feed must be fed for 28 days (21 CFR 558.140(d)(1)(iii)).
- The Gator Preconditioning Weaning N medicated feed and CF Oxer medicated feed lists two different withdrawal periods, 48 hours and 7 days prior to slaughter. These feeds include a combination of chlortetracycline and sulfamethazine and the approval for cattle in 558.140(d)(1)(iii) lists a withdrawal period of 7 days prior to slaughter. In addition to the 48 hour withdrawal period being incorrect, listing two withdrawal periods is confusing as it makes it unclear to the user which of the two applies to the feed.
- The labels for the medicated feeds "Yearling 16%", Gator Preconditioning Weaning N, and CF Oxer do not contain the limitation statement in the approval, “a withdrawal period has not been established for this product in pre-ruminating calves” and do not to use in calves to be processed for veal (21 CFR 558.140(d)(1)(iii)).
5. Failure to ensure proper safety and effectiveness of the medicated feed by manufacturing a medicated feed that does not contain the labeled amount of drugs, as required by 21 CFR 225.42(a). Your firm manufactures a medicated feed, Yearling 16%, containing Aureo S 700, a Category II, Type A medicated article. The labeling for batches (b)(4), and (b)(4) of your Yearling 16% medicated feed indicate the drug level for chlortetracycline and sulfamethazine is 35 grams per ton for both drugs. However, the batch records indicate the medicated feed was formulated to provide (b)(4) grams per ton of each drug.
In addition, your firm is not registered with the Agency as a drug establishment as required under section 510 of the Act, 21 U.S.C. § 360, therefore all medicated feeds manufactured at your facility during the time your facility was not registered as a drug establishment are misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o).
We did not receive a response to the FDA Form 483 Inspectional Observations issued to you on August 20, 2015.
The above is not intended as an all-inclusive list of violations. As an animal feed manufacturer of 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.
Based on the results of the August 2015 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.
The specific violations noted in this letter and in the Form FDA 483, Inspectional Observation form, issued at the close-out of the inspection, may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the cause of the violations, take prompt actions to correct the violations and prevent their recurrence, to bring your products into compliance. Failure to achieve prompt corrective action may result in regulatory action, without further notice, such as seizure and/or injunction.
You should notify this office within fifteen (15) business 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 violations noted in this letter. If corrective action cannot be completed within 15 business 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 written reply to Erica M. Katherine, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Katherine can be reached at 407-475-4731 or Erica.Katherine@fda.hhs.gov
Susan M. Turcovski
Director, Florida District