Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-26.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2026 – 26 May 2026 | Human Drugs | 483 | View 483 → |
| 29 Aug 2022 – 7 Sep 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jan 2017 – 31 Jan 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2026
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Taichun Qin, Youkeun Kim
26 May 2026
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Taichun Qin, Youkeun Kim
26 May 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Taichun Qin, Youkeun Kim
7 Sep 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jonathan G Matrisciano, Margaret M Doherty
7 Sep 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jonathan G Matrisciano, Margaret M Doherty
Investigators
FDA investigators tied to this site in the record.
Taichun Qin1 insp.
Youkeun Kim1 insp.
Jonathan G Matrisciano1 insp.
Margaret M Doherty1 insp.
Felix Maldonado1 insp.
Tajah L Blackburn1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sterinova Inc.'s 3 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