FDA 483 - The Pet Apothecary LLC - August 07, 2018

The Pet Apothecary LLC, a producer of non-sterile drugs in Milwaukee, WI, received an FDA Form 483 following an inspection conducted from July 30 to August 7, 2018. The inspection revealed nine significant observations pertaining to the company's manufacturing and quality control processes.

Key issues included a lack of adequate containment and cleaning procedures for beta-lactam drug production, raising concerns about potential cross-contamination with other drug products. Cleaning methods were not formally established in writing, lacked specified agents, and did not ensure proper sanitization or segregation of clean/unclean equipment. Furthermore, analytical balances used for weighing drug components were not uniquely identified, regularly calibrated, or checked with certified weights, and no maintenance records were available.

Production records were found to be deficient, missing critical information such as material manufacturers, lot numbers, expiry dates, equipment identification, and verification of weights/volumes. The facility also lacked an established training program for technicians and failed to ensure appropriate protective apparel was consistently worn, posing risks of product contamination. The FDA noted the absence of written procedures for managing quality-related events like complaints, adverse event reporting, recalls, and deviations. Controls for material receipt and storage were inadequate, with materials not properly classified, segregated, or inventoried. Finally, Beyond Use Dates (BUDs) assigned to drug formulations were not formally established or supported by scientific data. The company is required to respond to these observations with a comprehensive plan for corrective and preventive actions.