FDA Policy/General

Multiple Animal Drug Violations Found at Vetix

David McFarland

— 2 min read
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A 5/2-6/3 FDA inspection at Vetix, Lexington, KY, found multiple violations in the firm’s distribution of animal drug products, according to a 10/12 Warning Letter from the agency’s Cincinnati District Office. Specific concerns on an FDA-483 included: 

  •          distributing unapproved new animal drugs — OptiMend, OptiVet, and Hy-Optic —which are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling;
  •          distribution of adulterated animal drugs that were found by FDA laboratory analysis to contain microbial growth, including Burkholderia cepacian (Hy-Optic), Burkholderia multivorans (Hy-Optic and OptiVet), Serratia marcescens (OptiMend), and Acinetobacter johnsonii (OptiMend);
  •          Current Good Manufacturing Practice violations including:

o   failing to establish in writing and fully follow certain responsibilities and procedures applicable to the quality control unit;

o   failing to ensure testing of drug product including appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient before release;

o   failing to ensure drug products bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality, and purity at the time of use;

o   failing to ensure there are written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;

o   failing to ensure that the establishment of specifications including any changes to them are drafted, reviewed, and approved by the appropriate organizational unit; and

o   failing to ensure that the reserve sample of drug product consists of at least twice the quantity necessary to perform all the required tests of drug product.

FDA acknowledges the firm’s commitment to stop manufacturing and distributing OptiMend, OptiVet, and Hy-Optic, and acknowledges its August product recall. It also acknowledges that the company is working to develop and implement procedures to bring its facility into compliance with CGMP regulations, but says the agency “still has concerns regarding your firm’s compliance with CGMP regulations.”

Vetix was told to take prompt action to correct the violations and prevent their recurrence and to respond with a list of steps taken since the inspection, documentation of each step, and a timetable for completion.

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