Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-12-12.
At a glance
Inspections
2
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Dec 2018 – 12 Dec 2018 | Human Drugs | Clean | |
| 13 Apr 2015 – 16 Apr 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Apr 2015
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Reba A Gates, Jawaid Hamid
16 Apr 2015
21 CFR 212.40(d)
Contamination, mix-ups and deterioration
Cited by Reba A Gates, Jawaid Hamid
16 Apr 2015
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Reba A Gates, Jawaid Hamid
16 Apr 2015
21 CFR 212.40(d)
Contamination, mix-ups and deterioration
Cited by Reba A Gates, Jawaid Hamid
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.40(d) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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