EyePoint Pharmaceuticals US, Inc.
FDA inspection history in Watertown, Massachusetts, 2019 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Watertown, Massachusetts.
- 2019The longest 483 on file: 9 observations over 13 pages at Watertown, Massachusetts.
- 2024One warning letter and one Form 483, at Watertown, Massachusetts.
Cited most
Across all EyePoint Pharmaceuticals US observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
The complete EyePoint Pharmaceuticals US file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Watertown, Massachusetts
Two Form 483s and one warning letter · 2019 to 2024 · 16 observations
Latest: Warning letter, Jul 12, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-12 | Warning letter Warning letter | Watertown, Massachusetts | — | $99 |
| 2024-02-15 | 483 Form 483 | Watertown, Massachusetts | 7 | $99 |
| 2019-08-28 | 483 Form 483 | Watertown, Massachusetts | 9 | $99 |
Investigators on these documents
FEI number 3005508657 · most recent document Jul 12, 2024
About EyePoint Pharmaceuticals US, Inc.
How many FDA Form 483s has EyePoint Pharmaceuticals US, Inc. received?
FDA Intel has 2 Form 483s on file for EyePoint Pharmaceuticals US, Inc.; the most recent is dated Feb 15, 2024.
When was EyePoint Pharmaceuticals US, Inc. last inspected by FDA?
The most recent FDA inspection document on file for EyePoint Pharmaceuticals US, Inc. is a Form 483 dated Feb 15, 2024, for the site in Watertown, Massachusetts.
What did FDA cite at EyePoint Pharmaceuticals US, Inc.?
The regulations cited most in the observations on file for EyePoint Pharmaceuticals US, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times.
Has EyePoint Pharmaceuticals US, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for EyePoint Pharmaceuticals US, Inc.; the most recent is dated Jul 12, 2024.