FDA EIR - Zoetis, LLC - November 17, 2023

Zoetis, LLC underwent an FDA surveillance inspection at its Salisbury, MD facility from November 14 to 17, 2023. The inspection aimed to assess compliance with Good Manufacturing Practices (GMP) for Type A Medicated Articles, covering products like Avatec, Bovatec, Zoamix, and Robenz, under regulatory frameworks including Compliance Program 7371.005. The previous inspection's observation concerning drug component handling was verified as corrected.

However, the current inspection identified two significant issues, detailed in an FDA Form 483. Firstly, the company failed to take appropriate and effective action in response to product complaints (citing 21 CFR 226.115). This included recurring problems with Bovatec 91 bags missing lot and expiration dates across three separate incidents, where corrective actions were insufficient and lacked effectiveness checks. Additionally, a complaint about large white clumps in Bovatec 91 due to mechanical failure was not adequately addressed to prevent recurrence. Secondly, drug components were not consistently received, examined, or tested to ensure their integrity, evidenced by the discovery of a dead insect in a Quality Control sample.

At the inspection's close, Zoetis's Plant Manager was issued the FDA 483 and committed to submitting a written response addressing the observations within 15 business days.