# FDA WARNING_LETTER - California Pharmacy & Compounding Center - October 17, 2014

Source: https://www.keypedia.com/records/warning_letter/california-pharmacy-compounding-center/565ef235-df5b-4460-a90a-04c9ccb32421

> FDA WARNING_LETTER for California Pharmacy & Compounding Center on October 17, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: California Pharmacy & Compounding Center
- Inspection Date: 2014-10-17
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: On June 17, 2015, the FDA issued a Warning Letter to California Pharmacy & Compounding Center (CPCC) following inspections from August 18-25, 2014, and October 14-17, 2014. CPCC, registered as an outsourcing facility under FDCA section 503B, was cited for serious deficiencies in sterile drug production, rendering products adulterated and misbranded.

Key violations include:
- **Insanitary Conditions (501(a)(2)(A) FDCA):** Failure to monitor pressure differential between cleanroom and anteroom, and absence of environmental monitoring during sterile production periods (Jan-June 2014), posing contamination risk.
- **CGMP Violations (501(a)(2)(B) FDCA):** Lack of written procedures for preventing microbiological contamination and validating aseptic processes (21 CFR 211.113(b)); inadequate personnel gowning (21 CFR 211.28(a)); insufficient environmental monitoring system (21 CFR 211.42(c)(10)(iv)); failure to investigate discrepancies (21 CFR 211.192); and inadequate equipment maintenance for aseptic conditions (21 CFR 211.42(c)(10)(vi)).
- **Failure to Meet 5

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## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/william-s-vitale/385264da-862e-4f94-a796-c44a76dadd3f)
- [ Executive Officer](https://www.keypedia.com/people/virginia-herold/51027c34-876b-4ed0-8fd0-351f70330a3c)
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Company: https://www.keypedia.com/companies/california-pharmacy-compounding-center/d5604546-24b5-4923-acef-416e6a07d32e

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b