Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-08.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jul 2025 – 8 Aug 2025 | Human Drugs | 483 | View 483 → |
| 14 May 2024 – 29 May 2024 | Human Drugs | 483 | View 483 → |
| 14 Feb 2022 – 2 Mar 2022 | Human Drugs | 483 | View 483 → |
| 6 Apr 2018 – 13 Apr 2018 | Human Drugs | 483 | View 483 → |
| 17 Nov 2014 – 4 Dec 2014 | Human Drugs | WL | View 483 → |
| 4 Mar 2013 – 21 Mar 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 May 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Libia M Lugo, Kayla V Sprague, Logan T Williams, Jessica P Mcalister
29 May 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Libia M Lugo, Kayla V Sprague, Logan T Williams, Jessica P Mcalister
Investigators
FDA investigators tied to this site in the record.
Jessica P Mcalister2 insp.
Joanne E King2 insp.
Jose R Lopez1 insp.
Libia M Lugo1 insp.
Kayla V Sprague1 insp.
Logan T Williams1 insp.
Susan O Oladeji1 insp.
Clinton J Lott1 insp.
Camerson E Moore1 insp.
Caryn M Mcnab1 insp.
Brooke K Higgins1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 2x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.87 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Olympia Pharmaceuticals' 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