# FDA 483 - INCELL Corporation LLC - September 01, 2015

Source: https://www.keypedia.com/records/483/incell-corporation-llc/9aba0cea-8793-41e5-a32b-1192319b2106

> FDA 483 for INCELL Corporation LLC on September 01, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: INCELL Corporation LLC
- Inspection Date: 2015-09-01
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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.

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## Related Officers

- [ Investigator ](https://www.keypedia.com/people/patrice-s-hall/b58acfc0-fa18-4425-9a51-92267a2a6491)

Company: https://www.keypedia.com/companies/incell-corporation-llc/d4d60997-99ce-45b7-be66-c76ff6e80ec5

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9