FDA 483 - Pharmacy Resources Incorporated - January 29, 2019

The FDA Form 483 documents deficiencies at a facility producing sterile, intrathecal, and epidural drug products for human use, and sterile veterinary drugs. The facility utilizes ISO-5 workstations within an ISO-7 cleanroom.

Key observations include: 1. **Aseptic Processing Area Deficiencies:** * Cleaning and disinfection system for ISO-5 and ISO-7 areas is inadequate. * Sporicidal disinfectant use is inconsistent and not routinely applied to ISO-7 cleanroom surfaces (floors, walls, ceilings). * Cleaning records for ISO-5 workbenches between June 1, 2018, and December 30, 2018, incorrectly documented disinfectant use, and the disinfectant's sporicidal properties were not confirmed. * Non-sterile cleaning wipes are used in ISO-5 workbenches. * Non-cleanable items (clock radio, wall-mounted intercom) were present in the ISO-7 cleanroom.

2. **Sterilization Process Validation:** * No in situ air pattern analysis (smoke studies) conducted under simulated normal operating conditions in cleanrooms, laminar-flow hoods, or biosafety cabinets.

3. **Protective Apparel:** * Non-sterile shoe covers, bouffant hair covers, face masks/shields, and gowns (sprayed with non-sterile solution