# FDA 483 - Pillar Biosciences Inc. - September 16, 2025

Source: https://www.keypedia.com/records/483/pillar-biosciences-inc/f5236b8a-243d-4904-8646-ff97513a53eb

> FDA 483 for Pillar Biosciences Inc. on September 16, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pillar Biosciences Inc.
- Inspection Date: 2025-09-16
- Product Type: other
- Office Name: New England District Office
- Summary: An FDA inspection of Pillar Biosciences Inc. in Natick, MA, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to consistently meet CAPA timeline requirements, adequately document extensions, and ensure consistency between its CAPA-related standard operating procedures. These issues indicate a breakdown in the firm's quality system regarding corrective and preventive actions.

## Related Documents

- [483 - 2021-06-04](https://www.keypedia.com/records/483/pillar-biosciences-inc/d5267f19-4ee5-42ee-9ea3-31f7863d0eeb)

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/pillar-biosciences-inc/1c6fed36-4a2b-4324-981a-7a099a754c4f

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144