FDA 483 - The Compounding Pharmacy - September 29, 2021

The FDA Form 483 details observations from an inspection concerning facility design, equipment cleanliness, and sterilization processes.

**Facility and Operations:** The facility includes ISO 7 classified cleanrooms ((b)(4) and (b)(4)) where sterile products (intrathecal, intravitreal, intravenous, intramuscular) are compounded within close proximity (3-8 feet) of mini-split air conditioning (AC) units.

**Violations and Observations:**

1. **Air Quality Compromise:** * Mini-split AC units in ISO 7 cleanrooms, containing condensers and fans, are particle-generating equipment without HEPA filtration, potentially compromising the ISO 5 area. * A hole for the AC unit's drain tube in cleanroom (b)(4) showed air movement from an unclassified space, indicating an unsealed connection. * A gap between the AC unit in cleanroom (b)(4) and the wall suggests an unsealed connection. * Stagnant water with black deposition and a white spot was observed in the drain tube on the unclassified side. * AC unit vents are positioned to potentially blow directly into the ISO 5 aseptic processing area.

2. **Difficult-to-Clean/Dirty Equipment/Surfaces:** * AC units in cleanrooms (b)(4) and (b)(4) are surrounded by non-clean