Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-08.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Dec 2022 – 8 Dec 2022 | Human Drugs | 483 | View 483 → |
| 14 Sep 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Dec 2022
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Zachary L Stamm, Ashar P Parikh
8 Dec 2022
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Zachary L Stamm, Ashar P Parikh
8 Dec 2022
21 CFR 211.194(a)(2)
Suitability of testing methods verified
Cited by Zachary L Stamm, Ashar P Parikh
8 Dec 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Zachary L Stamm, Ashar P Parikh
8 Dec 2022
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Zachary L Stamm, Ashar P Parikh
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 Form 483s
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