Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-17.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 17 May 2024 | Human Drugs | 483 | View 483 → |
| 21 Sep 2022 – 30 Sep 2022 | Human Drugs | 483 | View 483 → |
| 21 Oct 2003 | Not recorded | Clean | |
| 15 Jul 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2024
21 CFR 58.31(b)
Management: replacing the study director
Cited by Erin M Mcdowell, Anthony J Grace
17 May 2024
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Erin M Mcdowell, Anthony J Grace
30 Sep 2022
21 CFR 58.31(e)
Management: availability of resources
Cited by Betsy C Galliher, Lynda L Lanning
30 Sep 2022
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Betsy C Galliher, Lynda L Lanning
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 58.81(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.31(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 Form 483s
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