# FDA 483 - Pillar Biosciences Inc. - June 04, 2021

Source: https://www.keypedia.com/records/483/pillar-biosciences-inc/d5267f19-4ee5-42ee-9ea3-31f7863d0eeb

> FDA 483 for Pillar Biosciences Inc. on June 04, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pillar Biosciences Inc.
- Inspection Date: 2021-06-04
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Pillar Biosciences Inc. in Natick, MA, a medical device manufacturer, identified two significant issues. The firm failed to adequately document process validation, specifically for its HVAC Monitoring and Control System's operation qualification. Additionally, calibration procedures lacked provisions for remedial action when monitoring and measuring equipment did not meet accuracy and precision limits.

## Related Documents

- [483 - 2025-09-16](https://www.keypedia.com/records/483/pillar-biosciences-inc/f5236b8a-243d-4904-8646-ff97513a53eb)

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94