FDA Inspection
EyePoint Pharmaceuticals, Inc.EyePoint Pharmaceuticals, Inc. – FDA Inspection, Apr 4, 2018
Record Details
This FDA Inspection record concerns EyePoint Pharmaceuticals, Inc., with an inspection on April 4, 2018, issued by the New England District Office, covering human drugs.
- People
- Edmund F. Mrak (FDA Associated Person)
- Steve Y. Rhieu (Company Rep)
- Yong Wang (Issuing Officer)
View Company Profile
ID · 0db9fefd-9ce7-4f02-8336-60414449746e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1046783
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.94(d)Written Procedures to Remove Pyrogens
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EyePoint Pharmaceuticals, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2024 | Not classified | New England District Office | Drug Quality Assurance |
| September 1, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 28, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2018 | Not classified | New England District Office |
Other documents for EyePoint Pharmaceuticals, Inc.
- FDA Inspection 1230113 - 2024-02-15
- FDA Inspection 1150669 - 2021-09-01
- FDA Inspection 1102130 - 2019-08-28
- FDA Inspection 1067552 - 2018-09-19
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.