# FDA 483 - California Pharmacy & Compounding Center - August 31, 2016

Source: https://www.globalkeysolutions.net/records/483/california-pharmacy-compounding-center/5d52aece-cf3d-4cb0-b3fe-15977471941f

> FDA 483 for California Pharmacy & Compounding Center on August 31, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: California Pharmacy & Compounding Center
- Inspection Date: 2016-08-31
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details observations from an inspection of an outsourcing facility. Key deficiencies relate to sterile drug product manufacturing and labeling.

**Sterilization Process Validation:**
*   **Media Fills:** Inadequate, failing to simulate worst-case scenarios (e.g., longest production times, human interventions) as per WI-101-003-003. Specific examples include Bevacizumab PFS production not meeting maximum filling time. Growth promotion challenges lacked gram-negative bacteria and in-house representative isolates. Incorrect media was used for Lidocaine HCL/Phenylephrine HCL media fill. Rejected vials/syringes with particulates/defects were not included in incubation.
*   **Smoke Studies:** Conducted on (b) (4) for ISO 5 Laminar Flow Hoods, but not under dynamic conditions. They failed to assure unidirectional airflow under working conditions and ingress prevention of ISO 7 air into ISO 5. Components/equipment (e.g., (b) (4)) and operator movements were not included.

**Environmental Monitoring & Air Supply:**
*   **Personnel Monitoring:** Lacks scientific rationale to assure aseptic processing. Samples (e.g., around (b) (4)) were taken (b) (4).
*   **HEPA Filter Certification:** (b) (4) certifications for ISO 7 and ISO 8 rooms did not include HEPA filter leak testing for filters

## Related Documents

- [483 - 2014-08-25](https://www.globalkeysolutions.net/records/483/california-pharmacy-compounding-center/910f9dc9-5efa-4441-9c0e-ee0bf62756a7)
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- [WARNING_LETTER - 2014-10-17](https://www.globalkeysolutions.net/records/warning_letter/california-pharmacy-compounding-center/565ef235-df5b-4460-a90a-04c9ccb32421)
- [483 - 2017-04-21](https://www.globalkeysolutions.net/records/483/california-pharmacy-compounding-center/dc5c6cc4-f8ed-4125-9425-9895bfa1abb7)
- [AMENDED_483 - 2018-12-07](https://www.globalkeysolutions.net/records/amended_483/california-pharmacy-compounding-center/d8565f55-be32-49dc-a7c6-55fdc3499cc2)

## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.globalkeysolutions.net/companies/california-pharmacy-compounding-center/d5604546-24b5-4923-acef-416e6a07d32e

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