Ocular Therapculix, Inc.
FDA inspection history in Bedford, Massachusetts, 2016 to 2020
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Close-out
- Form 483
2016: one Form 483; 2017: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s, at Bedford, Massachusetts.
- 2016The longest 483 on file: 10 observations over 9 pages at Bedford, Massachusetts.
- 2020One close-out letter, at Bedford, Massachusetts.
Cited most
Across all Ocular Therapculix observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.101Charge-in of components1
- 21 CFR 211.103Calculation of yield1
The complete Ocular Therapculix 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
Bedford, Massachusetts
Two Form 483s and one close-out letter · 2016 to 2020 · 16 observations
Latest: Close-out, Sep 2, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-09-02 | Close-out Close-out letter | Bedford, Massachusetts | — | $99 |
| 2017-05-04 | 483 Form 483 | Bedford, Massachusetts | 6 | $99 |
| 2016-02-05 | 483 Form 483 | Bedford, Massachusetts | 10 | $99 |
Investigators on these documents
Edmund F. Mrak Jr (1)Jonathan G. Matrisciano (1)Nealie C. Newberger (1)
FEI number 3008477155 · most recent document Sep 2, 2020
About Ocular Therapculix, Inc.
How many FDA Form 483s has Ocular Therapculix, Inc. received?
FDA Intel has 2 Form 483s on file for Ocular Therapculix, Inc.; the most recent is dated May 4, 2017.
When was Ocular Therapculix, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Ocular Therapculix, Inc. is a Form 483 dated May 4, 2017, for the site in Bedford, Massachusetts.
What did FDA cite at Ocular Therapculix, Inc.?
The regulations cited most in the observations on file for Ocular Therapculix, Inc. are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.