# FDA 483 - California Pharmacy & Compounding Center - August 25, 2014

Source: https://www.keypedia.com/records/483/california-pharmacy-compounding-center/910f9dc9-5efa-4441-9c0e-ee0bf62756a7

> FDA 483 for California Pharmacy & Compounding Center on August 25, 2014. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: California Pharmacy & Compounding Center
- Inspection Date: 2014-08-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected California Pharmacy & Compounding Center, a 503B Outsourcing Facility in Newport Beach, CA, from August 18-25, 2014. The inspection revealed 15 observations related to deficiencies in facilities, equipment, quality systems, manufacturing, and labeling of sterile drug products.

Key violations include:
- **Environmental Monitoring:** Failure to conduct daily environmental monitoring of air, personnel, and surfaces in ISO 7 and ISO 5 areas, and lack of monitoring personnel and environmental bio-burden during production.
- **Contamination Control:** Deficiencies in preventing contamination, such as improper storage and reuse of sterilized stoppers, lack of closure container integrity testing, and a deficient cleanroom design with unclassified air exhaust vents, obstructed airflow, and no pressure differential monitoring.
- **Cleaning and Disinfection:** Inadequate frequency of cleanroom cleaning and disinfection, and lack of sporicidal cleaning agents for ISO 5 environments.
- **Equipment Qualification:** Absence of equipment qualification for sterilization and depyrogenation equipment, and no validation of sterilization methods for glass vials and rubber stoppers.
- **Personnel Gowning:** Inadequate gowning practices, including the use of non-sterile face masks, hair nets, and shoe covers, exposed street scrubs, lack of sterile goggles, facial skin exposure, and employees bringing personal electronic devices into aseptic areas.
- **Investigation of Discrepancies:** Failure to document investigations into

## Related Documents

- [483 - 2014-10-17](https://www.keypedia.com/records/483/california-pharmacy-compounding-center/d787da6c-fe92-40a5-ae05-cefdf58a1e4d)
- [WARNING_LETTER - 2014-10-17](https://www.keypedia.com/records/warning_letter/california-pharmacy-compounding-center/565ef235-df5b-4460-a90a-04c9ccb32421)
- [483 - 2016-08-31](https://www.keypedia.com/records/483/california-pharmacy-compounding-center/5d52aece-cf3d-4cb0-b3fe-15977471941f)
- [483 - 2017-04-21](https://www.keypedia.com/records/483/california-pharmacy-compounding-center/dc5c6cc4-f8ed-4125-9425-9895bfa1abb7)
- [AMENDED_483 - 2018-12-07](https://www.keypedia.com/records/amended_483/california-pharmacy-compounding-center/d8565f55-be32-49dc-a7c6-55fdc3499cc2)

## Related Officers

- [Investigator](https://www.keypedia.com/people/binh-t-nguyen/14ca5620-1f92-4f5d-8663-3b63814aca26)
- [Ademola O. Daramola](https://www.keypedia.com/people/ademola-o-daramola/814113a4-38bc-4ce5-b6af-09c7e688c0ec)
- [Investigator](https://www.keypedia.com/people/binh-t-daramola/882b477d-3e91-4622-9013-4dbe617ab305)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c