Overview
- 12 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-20.
At a glance
Inspections
12
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2024 – 20 Sep 2024 | Human Drugs | 483 | View 483 → |
| 8 Apr 2019 – 12 Apr 2019 | Human Drugs | 483 | View 483 → |
| 24 Oct 2016 – 28 Oct 2016 | Human Drugs | Clean | |
| 3 Aug 2015 – 14 Aug 2015 | Human Drugs | 483 | On file |
| 26 Oct 2012 | Not recorded | Clean | |
| 8 Apr 2011 | Not recorded | Clean | |
| 9 Aug 2010 | Not recorded | Clean | |
| 8 Aug 2008 | Not recorded | Clean | |
| 23 Jun 2006 | Not recorded | Clean | |
| 16 Jul 2004 | Not recorded | Clean | |
| 2 Jul 2002 | Not recorded | Clean | |
| 16 Jun 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2024
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by William V Millar, Rodney L Tinzie
20 Sep 2024
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by William V Millar, Rodney L Tinzie
20 Sep 2024
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by William V Millar, Rodney L Tinzie
20 Sep 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by William V Millar, Rodney L Tinzie
20 Sep 2024
21 CFR 211.67(b)
Written procedures fail to include
Cited by William V Millar, Rodney L Tinzie
Investigators
FDA investigators tied to this site in the record.
Marie F Morin3 insp.
Marvin D Jones2 insp.
William V Millar1 insp.
Rodney L Tinzie1 insp.
Claire M Minden1 insp.
Tracy J Washington1 insp.
Brandon C Heitmeier1 insp.
June P Page1 insp.
Brittny M Mitchell1 insp.
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 | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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