Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-04-13.
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 |
|---|---|---|---|
| 15 Mar 2022 – 13 Apr 2022 | Human Drugs | 483 | View 483 → |
| 8 Sep 2020 – 5 Oct 2020 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Oct 2020
21 CFR 211.167(a)
Sterility/pyrogen-free testing
Cited by Kenneth O Gee, Nathaniel B Phillips Sylvain
5 Oct 2020
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Kenneth O Gee, Nathaniel B Phillips Sylvain
5 Oct 2020
FDCA 503B(a)(10)
Drug product label, outsourcer facility
Cited by Kenneth O Gee, Nathaniel B Phillips Sylvain
5 Oct 2020
FDCA 503B(b)(2)(A)
Outsourcing facility, compounded drug report follow up
Cited by Kenneth O Gee, Nathaniel B Phillips Sylvain
Investigators
FDA investigators tied to this site in the record.
Kenneth O Gee2 insp.
Nathaniel B Phillips Sylvain1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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