Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-07.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jan 2025 – 7 Feb 2025 | Human Drugs | 483 | View 483 → |
| 7 Dec 2023 – 15 Dec 2023 | Human Drugs | 483 | View 483 → |
| 13 Feb 2020 – 21 Feb 2020 | Human Drugs | 483 | View 483 → |
| 14 May 2018 – 17 May 2018 | Human Drugs | Clean | |
| 22 Jan 2018 – 26 Jan 2018 | Animal Drugs & Feeds | 483 | View 483 → |
| 2 Feb 2015 – 6 Feb 2015 | Human Drugs | 483 | View 483 → |
| 27 May 2013 – 31 May 2013 | Human Drugs | Clean | |
| 22 Jul 2011 | Not recorded | Clean | |
| 17 Oct 2008 | Not recorded | 483 | View 483 → |
| 18 Apr 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Feb 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Patty P Kaewussdangkul, Miguel A Martinez
7 Feb 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Patty P Kaewussdangkul, Miguel A Martinez
7 Feb 2025
21 CFR 211.166(a)
Written program not followed
Cited by Patty P Kaewussdangkul, Miguel A Martinez
7 Feb 2025
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Patty P Kaewussdangkul, Miguel A Martinez
7 Feb 2025
21 CFR 211.170(b)
Drug product reserve containers
Cited by Patty P Kaewussdangkul, Miguel A Martinez
Investigators
FDA investigators tied to this site in the record.
Patty P Kaewussdangkul1 insp.
Miguel A Martinez1 insp.
Saundrea A Munroe1 insp.
Sarah E Rhoades1 insp.
Tamara J Henderson1 insp.
Alan P Kurtzberg1 insp.
Satheesh Thomas1 insp.
Simone E Pitts1 insp.
Alice S Tsao1 insp.
Noreen Muniz1 insp.
Patrick L Wisor1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 11 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | 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(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pillar5 Pharma Inc's 6 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