Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-24.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Feb 2023 – 24 Feb 2023 | Human Drugs | Clean | |
| 4 Jun 2018 – 15 Jun 2018 | Human Drugs | Clean | |
| 10 Oct 2016 – 18 Oct 2016 | Human Drugs | 483 | View 483 → |
| 2 Mar 2015 – 10 Mar 2015 | Human Drugs | 483 | On file |
| 17 Jun 2013 – 25 Jun 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2016
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Brian D Nicholson
Investigators
FDA investigators tied to this site in the record.
MRA B KambereM1 insp.
Alice S Tsao1 insp.
Brian D Nicholson1 insp.
Libia M Lugo1 insp.
Liming Zhang1 insp.
S. L Brown1 insp.
Steven C Madzo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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