FDA Inspection
Ocular Therapeutix Inc.Ocular Therapeutix Inc. – FDA Inspection, May 4, 2017
Record Details
This FDA Inspection record concerns Ocular Therapeutix Inc., with an inspection on May 4, 2017, issued by the New England District Office, covering human drugs.
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ID · 4f9c6795-174d-4757-afcf-b33cd125edee
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1012195
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
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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 |
| October 26, 2018 | VAI | 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 1069931 - 2018-10-26
- FDA Inspection 964143 - 2016-02-11
- FDA Inspection 918538 - 2015-03-11
- FDA Inspection 834075 - 2013-06-03
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