Florida feed company warned on unclear labels, medicated feed management
The Florida-based company was cited for not following current good manufacturing practice regulations for its medicated feeds as listed in federal regulation and the Federal Food, Drug and Cosmetic Act, said officials with the FDA in the letter. “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)],” they added.
“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,” they said. “This letter constitutes official notification under the law and provides you an opportunity to correct the deficiencies in your operations.”
The problems noted may be an indication that there are significant issues with the company’s current procedure for quality assurance, said officials. “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,” they added.
Some of the feed products also are considered to be misbranded because of potentially unclear labels, they said.
Additionally, the company was notified that the FDA had not received a response regarding the results of the August inspection.
Details of potential violations
The letter outlined five areas where violations were found during a three-day inspection in August, said officials with the FDA. The comments made may not have addressed all the problems found and do not constitute a complete list.
Those specifically enumerated included that the company has failed to assay on its medicated feeds, they said. Checking samples of medicated feeds for each drug or combination is required throughout the year.
The company also was critiqued for not maintaining a “complete and accurate” master record file, said officials. The files were missing manufacturing instructions and control instructions for some feeds, and files were not signed or initial by the correct person.
“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),” they said. “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.”
The company also did not have appropriate labels on all of its medicated feed products, said officials. Some labels did not include clear use directions regarding how much feed should be used and when, and other labels offered confusing information on withdrawal periods.
“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,” they said. “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.”
Some of the medicated feeds also did not include the correct amount of the drugs included, they said. The labeling for some product batches specified that a certain amount of the drugs chlortetracycline and sulfamethazine was included, but batch records did not match.
Additionally, the company was not correctly registered with the FDA, said officials. “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,” they added.
Gator Feeds has been asked to outline and explain the steps it has taken or plans to take to address the comments, said officials.
“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,” they said. “Include copies of any available documentation demonstrating that corrections have been made.”
The company did not return a call for comment by press time.
