Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-04-11.
At a glance
Inspections
4
Form 483s
2
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2019 – 11 Apr 2019 | Human Drugs | 483 | View 483 → |
| 18 Sep 2017 – 22 Sep 2017 | Human Drugs | 483 | On file |
| 10 Dec 2014 – 12 Dec 2014 | Human Drugs | Clean | |
| 11 Mar 2013 – 14 Mar 2013 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Apr 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Doan T Nguyen, Doan N Singh
11 Apr 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Doan T Nguyen, Doan N Singh
Investigators
FDA investigators tied to this site in the record.
Doan T Nguyen1 insp.
Doan N Singh1 insp.
Noreen Muniz1 insp.
Scott T Ballard1 insp.
Santos E Camara1 insp.
Christopher T Middendorf1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 |
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