FDA Inspection
Intrinsic Therapeutics, Inc.Intrinsic Therapeutics, Inc. – FDA Inspection, Jun 16, 2015
Record Details
This FDA Inspection record concerns Intrinsic Therapeutics, Inc., with an inspection on June 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Intrinsic Therapeutics, Inc.
- Inspection Date
- June 16, 2015
- Product Type
- Devices
View Company Profile
ID · 9131ed6e-24f4-4140-a17d-c11b5631c545
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 932632
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(c)Management review participants
- 21 CFR 820.70(c)Environmental control system-documentation/review inspection
- 21 CFR 820.70(g)(1)Activity documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Intrinsic Therapeutics, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | Not classified | New England District Office | |
| July 21, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 29, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 31, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 14, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Intrinsic Therapeutics, Inc.
- FDA Inspection 1284766 - 2025-09-26
- FDA Inspection 1177590 - 2022-07-21
- FDA Inspection 1030073 - 2017-09-29
- FDA Inspection 1010081 - 2017-03-31
- FDA Inspection 772186 - 2012-03-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.