# FDA 483 - APC Pharma Carlsbad - Unknown Date

Source: https://www.keypedia.com/records/483/apc-pharma-carlsbad/5812d3ec-239f-4bf2-92a3-63a6a1873af8

> FDA 483 for APC Pharma Carlsbad on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APC Pharma Carlsbad
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: APC Pharma Carlsbad, a biologics manufacturer in Carlsbad, CA, was cited for six observations during an FDA inspection. The inspection revealed significant issues primarily related to aseptic processing, contamination control, equipment management, and procedural deficiencies, indicating a lack of adequate controls to ensure product quality and sterility. These conditions suggest a moderate level of severity regarding compliance with manufacturing standards.

## Related Officers

- [Don Donald Enslin, Lead Investigator](https://www.keypedia.com/people/don-donald-enslin-lead-investigator/8518f24e-4947-4c25-bbdd-49b1f804c212)
- [Michael Havert, Ph.D., Biologist](https://www.keypedia.com/people/michael-havert-phd-biologist/53704fd1-e736-489c-9370-565c305a1bb3)
- [Wei R. Jiang, Ph.D., Microbiologist](https://www.keypedia.com/people/wei-r-jiang-phd-microbiologist/4ca18e0e-e8d2-412d-bab1-6f5c2bed79f2)
- [Jakob Reiser, Ph.D., Research Biologist](https://www.keypedia.com/people/jakob-reiser-phd-research-biologist/29458707-3be1-4c56-81fe-e34b9bd44a78)

Company: https://www.keypedia.com/companies/apc-pharma-carlsbad/a07469ae-a26b-4996-8680-1e5031596fb5

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4