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

Source: https://www.keypedia.com/records/483/safc-carlsbad-inc/6adff0f3-3ab9-43d8-a303-57b470a3ec7a

> 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: Los Angeles District Office
- Summary: SAFC Carlsbad Inc., a viral vector manufacturer in Carlsbad, CA, was inspected by the FDA. The inspection revealed a significant failure to follow and establish written procedures for manufacturing equipment, specifically concerning maintenance, replacement, and testing of critical components. This indicates a lapse in quality system controls related to equipment management.

## Related Documents

- [EIR - 2019-09-12](https://www.keypedia.com/records/eir/safc-carlsbad-inc/c17935e6-3d7d-455f-9460-d8c1657967ec)
- [483 - 2019-09-12](https://www.keypedia.com/records/483/safc-carlsbad-inc/7e6a4cd0-7059-4724-ae33-a73dbb08ed11)
- [483 - 2021-12-16](https://www.keypedia.com/records/483/safc-carlsbad-inc/0f946838-aa1d-4198-85ab-fade476e008f)
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- [483 - 2025-08-14](https://www.keypedia.com/records/483/safc-carlsbad-inc/2a98166c-34e8-4a90-9b9f-5315c6afcfb4)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b