FDA Inspection
Ocular Therapeutix Inc.Ocular Therapeutix Inc. – FDA Inspection, Oct 26, 2018
Record Details
This FDA Inspection record concerns Ocular Therapeutix Inc., with an inspection on October 26, 2018, issued by the New England District Office, covering human drugs.
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ID · 7d7e78ec-1c79-4ff5-8b2e-126fae76893a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069931
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Ocular Therapeutix Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2017 | OAI | New England District Office | New Drug Evaluation |
| February 11, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 3, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Ocular Therapeutix Inc.
- FDA Inspection 1224953 - 2023-11-09
- FDA Inspection 1012195 - 2017-05-04
- FDA Inspection 964143 - 2016-02-11
- FDA Inspection 918538 - 2015-03-11
- FDA Inspection 834075 - 2013-06-03
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