Boothwyn Pharmacy LLC. — FDA 483 Findings

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

Aseptic processing areas are deficient regarding the system for monitoring environmental condit ions.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable s tandards of identity, strength, quality and purity at the time of use.

The final container closures used for drug product intended to be sterile have not been de-pyrogenated.

Procedures designed to prevent microbilogical contamination of drug products purporting to be sterile do not include a dequate validation of th e sterilization process.

Cleaning pads or wipes used in the ISO 5 aseptic processing areas are not sterile.

Biological indicators were not used to verify the adequacy of the sterilization cycle.

Media fills were not performed that closely stimulate aseptic production operatitons incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic oper ations.

Each batch of drug product purporting to be sterile and <Redact ed B4> is not laboratory tested to determine conforma nce to such requirements.

The calibration of instruments is not done at suitable intervals in accordance with an established written program.