Overview
- 13 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
At a glance
Inspections
13
Form 483s
6
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 May 2026 – 15 May 2026 | Foods & Cosmetics | 483 | View 483 → |
| 21 Jul 2022 – 26 Jul 2022 | Foods & Cosmetics | 483 | View 483 → |
| 23 Aug 2018 | Foods & Cosmetics | Clean | |
| 13 Feb 2018 – 16 Feb 2018 | Human Drugs | 483 | View 483 → |
| 23 Jun 2015 – 30 Jun 2015 | Human Drugs | 483 | View 483 → |
| 7 Nov 2013 – 8 Nov 2013 | Human Drugs | Clean | |
| 7 Sep 2012 | Not recorded | Clean | |
| 1 Jun 2011 | Not recorded | 483 | View 483 → |
| 23 Mar 2010 | Not recorded | 483 | View 483 → |
| 5 Feb 2009 | Not recorded | Clean | |
| 3 Jul 2007 | Not recorded | Clean | |
| 25 Jul 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2026
21 CFR 111.315(d)
Standard reference materials; criteria for selecting
Cited by Meredith P Soehl, Jung K Kim
15 May 2026
21 CFR 111.70(e)
Specifications - finished dietary supplement
Cited by Meredith P Soehl, Jung K Kim
Investigators
FDA investigators tied to this site in the record.
Charisse K Green3 insp.
Meredith P Soehl2 insp.
Christopher S Fields2 insp.
Jung K Kim1 insp.
Jose O Hernandez1 insp.
Deborah J Parris1 insp.
Alice S Tsao1 insp.
Sony Mathews1 insp.
Thomas J Mooney1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | 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 Gemini Pharmaceuticals, 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