# FDA 483 - SAFC Carlsbad Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/safc-carlsbad-inc/7e6a4cd0-7059-4724-ae33-a73dbb08ed11

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

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## Details

- Record Type: 483
- Company Name: SAFC Carlsbad Inc.
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of SAFC Carlsbad, Inc. in Carlsbad, CA, a manufacturer of viral vectors, identified eight observations related to deficiencies in environmental monitoring, label control, supplier qualification, equipment qualification, raw material inspection, consumable equipment qualification, environmental monitoring incubation conditions, and functional training. The findings indicate several areas where the firm's quality systems and controls require improvement to ensure product quality and compliance.

## Related Documents

- [EIR - 2021-12-16](https://www.keypedia.com/records/eir/safc-carlsbad-inc/f511c01e-984a-437c-91b4-c74a97019eb8)
- [483 - 2021-12-16](https://www.keypedia.com/records/483/safc-carlsbad-inc/0f946838-aa1d-4198-85ab-fade476e008f)

## Related Officers

- [Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics](https://www.keypedia.com/people/steven-e-bowen/0e32c7e6-285b-4cf1-90e1-8a7a12a38b0c)
- [Gena Arcy, CSO](https://www.keypedia.com/people/gena-arcy-cso/5e73742f-22df-4750-82a8-430f86192916)

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

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