FDA 483 - Unknown Company - August 22, 2014

This FDA Form 483, issued to Sina LLC, dba OncoMed (Onco360), a producer of sterile drugs located in Great Neck, New York, details observations from an inspection conducted on August 07, 08, 11, 14, 22, 2014.

The inspection revealed nine observations concerning the firm's sterile drug production. Key deficiencies include:

1. **Aseptic Processing Area Deficiencies:** Smoke studies were not performed under dynamic conditions in ISO-5 biological safety cabinets (BSCs) and laminar flow hoods (LAFWs). A ductless air conditioning unit in the ISO-7 cleanroom adjacent to an ISO-5 BSC posed a contamination risk. Wall-mounted room air-pressure monitors were not continuously monitored, lacking alarms or central monitoring. An automated tablet/capsule counter was used near ISO-5 BSCs, potentially dispersing dust from cytotoxic/mutagenic products. A wall-mounted hand air-dryer in the ISO-7 ante room created a contamination risk.

2. **Personnel Clothing:** An operator preparing sterile drug products wore non-sterile gowns, facial masks, and hair bonnets.

3. **Environmental Monitoring Deficiencies:** Viable air counts in ISO-5 hoods were not performed at least (b)(4) during sterile processing. Work surfaces inside ISO-5 hoods were not sampled for microbial contamination at least