Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-06-05.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jun 2024 – 5 Jun 2024 | Human Drugs | Clean | |
| 23 Apr 2019 – 25 Apr 2019 | Human Drugs | 483 | On file |
| 31 Mar 2014 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Apr 2019
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by William J Leonard
25 Apr 2019
21 CFR 211.194(a)(4)
Complete Test Data
Cited by William J Leonard
25 Apr 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by William J Leonard
25 Apr 2019
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by William J Leonard
25 Apr 2019
21 CFR 211.194(a)(4)
Complete Test Data
Cited by William J Leonard
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 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(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