Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-04-19.
At a glance
Inspections
4
Form 483s
3
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Apr 2018 – 19 Apr 2018 | Human Drugs | 483 | View 483 → |
| 20 Jul 2015 – 29 Jul 2015 | Human Drugs | 483 | View 483 → |
| 19 Feb 2013 – 25 Feb 2013 | Human Drugs | 483 | View 483 → |
| 26 Jul 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Apr 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Sangeeta M Khurana, Marijo B Kambere
19 Apr 2018
FDCA 503B(a)(10)
Container label, outsourcer facility
Cited by Sangeeta M Khurana, Marijo B Kambere
29 Jul 2015
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Roger F Zabinski, Sangeeta M Khurana
29 Jul 2015
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Roger F Zabinski, Sangeeta M Khurana
Investigators
FDA investigators tied to this site in the record.
Sangeeta M Khurana2 insp.
Marijo B Kambere1 insp.
Roger F Zabinski1 insp.
Sonia R Peterson1 insp.
Joey V Quitania1 insp.
Kenneth Boehnen1 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 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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