# FDA 483 - SAFC Carlsbad Inc. - August 14, 2025

Source: https://www.keypedia.com/records/483/safc-carlsbad-inc/2a98166c-34e8-4a90-9b9f-5315c6afcfb4

> FDA 483 for SAFC Carlsbad Inc. on August 14, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SAFC Carlsbad Inc.
- Inspection Date: 2025-08-14
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of SAFC Carlsbad Inc., a viral vector manufacturer, revealed a significant failure to adhere to and establish written procedures for manufacturing equipment. Specifically, the firm did not perform required maintenance and testing on equipment according to its own SOPs for several years, and lacked procedures for tracking and maintaining other critical equipment. This indicates a lapse in quality control and adherence to established manufacturing practices.

## Related Documents

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- [483 - 2025-08-14](https://www.keypedia.com/records/483/safc-carlsbad-inc/6adff0f3-3ab9-43d8-a303-57b470a3ec7a)

## Related Officers

- [Alan L. Truong](https://www.keypedia.com/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

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