# FDA 483 - AnaptysBio - April 29, 2026

Source: https://www.keypedia.com/records/483/anaptysbio/03bc24b8-54f7-4a3a-a5d7-ccfa2d0bdfd4

> FDA 483 for AnaptysBio on April 29, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AnaptysBio
- Inspection Date: 2026-04-29
- Product Type: other
- Office Name: Los Angeles District Office
- Summary: AnaptysBio, a sponsor of clinical studies in San Diego, CA, received a Form 483 for failing to adequately oversee and monitor its clinical trials. The inspection revealed significant deficiencies in monitoring plans, data query resolution, monitoring report sign-offs, and site qualification documentation. These issues indicate a lack of proper control over critical aspects of clinical study management.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/farwa-z-razvi/4ac4d0de-addf-4657-8756-0676015cea8a)

Company: https://www.keypedia.com/companies/anaptysbio/719b8042-9b20-4c2a-b273-49dc6524b06b

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