# FDA 483 - Gelesis, Inc. - January 25, 2023

Source: https://www.keypedia.com/records/483/gelesis-inc/3f438627-b1f4-433c-8fc1-bcab8310707b

> FDA 483 for Gelesis, Inc. on January 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gelesis, Inc.
- Inspection Date: 2023-01-25
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Gelesis, Inc. in Boston, MA, was inspected from January 19-25, 2023, revealing deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, with numerous CAPAs not meeting target completion dates or lacking effectiveness checks. Additionally, the inspection found that requirements for suppliers and contractors were not adequately established, as evidenced by missing re-qualification documentation for a Class A supplier.

## Related Officers

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

Company: https://www.keypedia.com/companies/gelesis-inc/ab1dbf70-1fab-4584-81fd-7ff5de4fa712

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