Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-06-19.
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 |
|---|---|---|---|
| 5 Jun 2017 – 19 Jun 2017 | Human Drugs | 483 | On file |
| 29 Oct 2014 – 13 Nov 2014 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Nov 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Emily J Orban, Sarah M Meng, Sarah M Napier
13 Nov 2014
21 CFR 211.28(a)
Clothing appropriate for duties performed
Cited by Emily J Orban, Sarah M Meng, Sarah M Napier
13 Nov 2014
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Emily J Orban, Sarah M Meng, Sarah M Napier
13 Nov 2014
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Emily J Orban, Sarah M Meng, Sarah M Napier
13 Nov 2014
21 CFR 211.42(d)
Penicillin processing area not kept separate
Cited by Emily J Orban, Sarah M Meng, Sarah M Napier
Investigators
FDA investigators tied to this site in the record.
Emilie Kahn1 insp.
Sarah E Rhoades1 insp.
Emily J Orban1 insp.
Sarah M Meng1 insp.
Sarah M Napier1 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 | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | 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 211.42(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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