Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-09.
At a glance
Inspections
8
Form 483s
6
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2023 – 9 Nov 2023 | Human Drugs | Clean | |
| 15 Oct 2018 – 26 Oct 2018 | Human Drugs | 483 | View 483 → |
| 24 Apr 2017 – 4 May 2017 | Human Drugs | 483 | View 483 → |
| 1 Feb 2016 – 11 Feb 2016 | Human Drugs | WL | On file |
| 6 Mar 2015 – 11 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 May 2013 – 3 Jun 2013 | Medical Devices & Rad Health | Clean | |
| 2 Apr 2013 – 26 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Apr 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Oct 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Sean R Marcsisin
Investigators
FDA investigators tied to this site in the record.
Frederick Razzaghi1 insp.
Sean R Marcsisin1 insp.
Nealie C Newberger1 insp.
Vidya B Pai1 insp.
Edmund F Mrak1 insp.
Jonathan G Matrisciano1 insp.
Aditi Thakur1 insp.
John A Sciacchitano1 insp.
Susanne M Richardson1 insp.
Tamara S Rosbury1 insp.
Stephen C Smith1 insp.
Matthew D Silverman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ocular Therapeutix, Inc.'s 6 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat