# FDA 483 - Antibodies Inc - March 10, 2023

Source: https://www.globalkeysolutions.net/records/483/antibodies-inc/456d81bb-c8b8-4e07-9756-85030e871f13

> FDA 483 for Antibodies Inc on March 10, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Antibodies Inc
- Inspection Date: 2023-03-10
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Antibodies Inc, a biological device and contract manufacturer in Davis, CA, received a Form FDA-483 with six observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate control of storage areas, undocumented acceptance of incoming products, and failures in complaint management, CAPA, equipment maintenance, and internal audit independence. These issues indicate a systemic lack of robust quality oversight and documentation practices.

## Related Officers

- [Creighton T. Tuzon](https://www.globalkeysolutions.net/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [Celeta S. Coves](https://www.globalkeysolutions.net/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

Company: https://www.globalkeysolutions.net/companies/antibodies-inc/2e214828-d2a8-4e09-8189-ac424c6ad7ed

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b