# FDA WARNING_LETTER - Pharmalucence, Inc. - April 30, 2008

Source: https://www.keypedia.com/records/warning_letter/pharmalucence-inc/1f3a4751-ee1e-47fa-93d6-8cd442935736

> FDA WARNING_LETTER for Pharmalucence, Inc. on April 30, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pharmalucence, Inc.
- Inspection Date: 2008-04-30
- Product Type: Drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Pharmalucence, Inc. from April 7-30, 2008, revealed significant deviations from cGMP regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Sterilization Process Deficiencies (21 CFR § 211.113(b)):** Failure to validate bacterial filtration retention for multiple aseptically filled products (e.g., CIS-PYRO, AN-DTPA, CIS-Sulfur Colloid), observed poor aseptic technique, inadequate validation of steam sterilization cycles (e.g., lack of steam penetration studies, no justification for worst-case loads, unvalidated load configurations), insufficient environmental and personnel monitoring (e.g., improper air sampler placement, unvalidated multi-location testing), un-evaluated microbiological burden from manual aseptic connections, and incomplete airflow pattern testing studies.
2.  **Inadequate Quality Control Investigations (21 CFR § 211.192):** Failure to thoroughly investigate environmental/personnel monitoring excursions (e.g., lack of root cause analysis, delayed initiation) and insufficient investigation into sterility testing issues for Iobenguane Sulfate I 131 (MIBG) Injection.
3.  **Container Suitability (21 CFR § 211.94(c)):** Unvalidated dep

## Related Officers

- [John R. Marzilli](https://www.keypedia.com/people/john-r-marzilli/0422092e-bccc-4c8d-91cb-17f4263a8851)
- [Compliance Officer](https://www.keypedia.com/people/amber-g-wardwell/6504fed9-7ee7-4af8-bac3-3ad7cc77414f)
- [Glenn Alto](https://www.keypedia.com/people/glenn-alto/795f9748-b72c-45d5-9818-394862500d6f)

Company: https://www.keypedia.com/companies/pharmalucence-inc/f31a9074-a3c5-4621-86ad-738c2dd2b8ab

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144