FDA 483 - INCELL Corporation LLC - September 01, 2015

An FDA Form 483 was issued detailing deficiencies in aseptic processing areas and procedures. The facility produces sterile (b)(4) (b)(4) and (b)(4) (b)(4).

**Violations and Observations:**

1. **Environmental Monitoring Deficiencies:** Pressure gauges are not installed to monitor pressure differentials or airflow between the ISO 7 Cleanroom (where (b)(4) Serial Number: (b)(4), Equipment ID: (b)(4) is located), the ISO 8 ante-room (for PPE donning), and the unclassified general environment. Two batches of (b)(4) were produced and distributed without pressure differential monitoring.

2. **Inadequate Microbiological Contamination Prevention Procedures:** * The firm does not perform (b)(4) on any sterile (b)(4) (b)(4). Two batches of (b)(4) were processed and distributed with (b)(4) (b)(4) and were not (b)(4). * Media fills are not performed by operators processing (b)(4) (b)(4) products. No written procedure simulates actual production or covers worst-case conditions. Routine production of the two (b)(4) batches involved filling (b)(4). * A smoke study conducted on (b)(4) for the (b)(4), ISO 5 zone, was not performed under dynamic conditions.