Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-15.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Feb 2024 – 15 Feb 2024 | Human Drugs | WL | View 483 → |
| 17 Aug 2021 – 1 Sep 2021 | Human Drugs | 483 | View 483 → |
| 29 Jul 2019 – 28 Aug 2019 | Human Drugs | 483 | View 483 → |
| 18 Sep 2018 – 19 Sep 2018 | Human Drugs | Clean | |
| 26 Mar 2018 – 4 Apr 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Feb 2024
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Sean R Marcsisin, Daniel L Zheng, Armen H Youssoufian
15 Feb 2024
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Sean R Marcsisin, Daniel L Zheng, Armen H Youssoufian
15 Feb 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Sean R Marcsisin, Daniel L Zheng, Armen H Youssoufian
15 Feb 2024
21 CFR 211.186(a)
Master production and control records, procedure
Cited by Sean R Marcsisin, Daniel L Zheng, Armen H Youssoufian
15 Feb 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sean R Marcsisin, Daniel L Zheng, Armen H Youssoufian
Investigators
FDA investigators tied to this site in the record.
Sean R Marcsisin2 insp.
Erik W Koester2 insp.
Daniel L Zheng1 insp.
Armen H Youssoufian1 insp.
Samir C Gala1 insp.
Chhaya S Shetty1 insp.
Edmund F Mrak1 insp.
Steve Y Rhieu1 insp.
Yong Wang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.94(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EyePoint US, Inc.'s 4 Form 483s
Source PDFs 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