Overview
- 17 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-01.
At a glance
Inspections
17
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jul 2025 – 1 Aug 2025 | Human Drugs | Clean | |
| 21 Jan 2025 – 28 Jan 2025 | Human Drugs | Clean | |
| 24 Jul 2023 – 2 Aug 2023 | Human Drugs | 483 | On file |
| 14 Sep 2021 – 15 Sep 2021 | Human Drugs | Clean | |
| 3 Feb 2020 – 6 Feb 2020 | Human Drugs | Clean | |
| 11 Feb 2019 – 22 Feb 2019 | Human Drugs | 483 | On file |
| 14 May 2018 – 15 May 2018 | Human Drugs | Clean | |
| 8 Jan 2018 – 12 Jan 2018 | Human Drugs | Clean | |
| 5 Jul 2016 – 8 Jul 2016 | Human Drugs | 483 | On file |
| 10 Aug 2015 – 20 Aug 2015 | Human Drugs | 483 | On file |
| 21 Jan 2014 – 22 Jan 2014 | Human Drugs | Clean | |
| 13 Sep 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jul 2016
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Adam R Cooke, Larry K Hampton, Constance Y Fears, Jason K Morgan, Jawaid Hamid
20 Aug 2015
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Joseph F Owens, Bonita S Chester
20 Aug 2015
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Joseph F Owens, Bonita S Chester
Investigators
FDA investigators tied to this site in the record.
Bonita S Chester4 insp.
Larry K Hampton2 insp.
Lareese K Thomas2 insp.
Penny H Mccarver2 insp.
Rodney L Tinzie1 insp.
Koffi A Amegadje1 insp.
Sonya M Edmonds1 insp.
Ann B Borromeo1 insp.
Deborah A Greco1 insp.
Jared P Stevens1 insp.
Samantha J Bradley1 insp.
Eileen J Bannerman1 insp.
Adam R Cooke1 insp.
Constance Y Fears1 insp.
Jason K Morgan1 insp.
Jawaid Hamid1 insp.
Joseph F Owens1 insp.
Trang N Cox1 insp.
Viviana Matta1 insp.
Ibad U Khan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PAI Holdings LLC's 7 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