# FDA 483 - SAFC Carlsbad Inc. - December 16, 2021

Source: https://www.globalkeysolutions.net/records/483/safc-carlsbad-inc/0f946838-aa1d-4198-85ab-fade476e008f

> FDA 483 for SAFC Carlsbad Inc. on December 16, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SAFC Carlsbad Inc.
- Inspection Date: 2021-12-16
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: SAFC Carlsbad Inc. in Carlsbad, CA, was inspected and cited for multiple deficiencies related to manufacturing controls and quality systems. Key issues include inadequate environmental controls, improper biohazardous waste management leading to cross-contamination risks, insufficient raw material identity testing, and deficiencies in aseptic process validation. These findings indicate a lack of robust controls to ensure product quality and safety.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/safc-carlsbad-inc/7e6a4cd0-7059-4724-ae33-a73dbb08ed11)
- [EIR - 2021-12-16](https://www.globalkeysolutions.net/records/eir/safc-carlsbad-inc/f511c01e-984a-437c-91b4-c74a97019eb8)

## Related Officers

- [Compliance Officer at FDA](https://www.globalkeysolutions.net/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)
- [Gene D. Arcy](https://www.globalkeysolutions.net/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)
- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.globalkeysolutions.net/companies/safc-carlsbad-inc/764cba2a-82e8-41a9-b19f-145bdafcd432

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6