FDA Inspection
Gelesis, Inc.Gelesis, Inc. – FDA Inspection, Jan 25, 2023
Record Details
This FDA Inspection record concerns Gelesis, Inc., with an inspection on January 25, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f3bc2214-2ff6-424c-801e-fec998b04eb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195457
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gelesis, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Gelesis, Inc.
- FDA Inspection 1076015 - 2018-12-17
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