The Pet Apothecary LLC — FDA 483 Findings

Criteria for Beyond Use Dates (BUDs) assigned to drug formulations produced by your pharmacy are not formally and appropriately established in a written procedure nor supported with cited literature references and/or stability studies.

Your pharmacy does not have an established training program for technicians nor do you maintain any training record documentation for on-the-job training that was provided to them.

Appropriate protective apparel is not always worn by technicians to protect drug products from contamination during production.

Analytical balances, used for weighing drug materials/components, are not uniquely identified nor appropriately calibrated on a periodic basis, nor periodically weight checked with an appropriate certified weight set.

Prescription production records are deficient in that they do not include the following: - name of manufacturers, lot numbers, and expiry dates of all materials/components used.

Cleaning methods are not established in a written procedure nor are appropriate cleaning agents specified.

Your pharmacy does not have established written procedures or adequate controls in place for receipt and storage of materials/components used to produce drug products.

Your pharmacy does not have established written procedures for handling and maintaining records for quality ­related events, such as for complaints, ADE/MedWatch reporting, recalls, deviations, and investigations.