# FDA WARNING_LETTER - Catalent Pharma Solutions - November 15, 2007

Source: https://www.keypedia.com/records/warning_letter/catalent-pharma-solutions/17cecc8f-9cf8-4ad7-b848-5430ce460ccf

> FDA WARNING_LETTER for Catalent Pharma Solutions on November 15, 2007. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Catalent Pharma Solutions
- Inspection Date: 2007-11-15
- Office Name: Office of Compliance and Enforcement
- Summary: An FDA inspection of Catalent Pharma Solutions (Raleigh, NC) from November 6-15, 2007, revealed significant deviations from current Good Manufacturing Practice (CGMP) in the manufacture of [redacted], violating Section 501(a)(2)(B) of the FD&C Act and 21 CFR Parts 210 and 211.

Key violations include:
1.  **Inadequate Quality Control Unit Investigations (21 CFR 211.192):** Failure to thoroughly investigate discrepancies, identify trends for environmental excursions (July-November 2007), and ensure timely completion of corrective actions (e.g., purified water loop heat exchanger not ordered, microbial identification delays).
2.  **Insufficient Aseptic Processing Controls (21 CFR 211.42(c)(10)(v)):** Delayed systematic facility cleaning for mold despite prolonged environmental excursions, and lack of disinfectant effectiveness studies against representative microorganisms.
3.  **Failure to Follow Sterile Product Procedures (21 CFR 211.113(b)):** Incomplete monitoring of Water for Injection use points, unreviewed environmental monitoring data by the quality unit, and failure to notify personnel of environmental monitoring excursions.
4.  **Unvalidated Test Methods (21 CFR 211.165(e)):** Sterility test method STR-MTM

## Related Officers

- [Principal](https://www.keypedia.com/people/david-k-elder/b9080f79-e8ae-46ac-9c68-1664961b03bf)

Company: https://www.keypedia.com/companies/catalent-pharma-solutions/116c1fdc-2010-431f-a250-a76b067af592

Office: https://www.keypedia.com/offices/office-of-compliance-and-enforcement/a993ea41-a073-4ddf-98d2-c53c77068fdb