Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-07.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 – 7 Nov 2025 | Human Drugs | 483 | View 483 → |
| 10 Sep 2025 – 30 Sep 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Dec 2022 – 21 Dec 2022 | Human Drugs | 483 | View 483 → |
| 31 May 2018 – 7 Jun 2018 | Human Drugs | 483 | View 483 → |
| 22 Mar 2016 – 5 Apr 2016 | Human Drugs | 483 | On file |
| 27 Mar 2014 – 3 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Feb 2013 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Sep 2025
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Shirley S Wen
Investigators
FDA investigators tied to this site in the record.
Norman K Starks1 insp.
Shirley S Wen1 insp.
Juanita P Versace1 insp.
Vivin George1 insp.
Nikisha M Bolden1 insp.
Nancy M Espinal1 insp.
Paul L Bellamy1 insp.
Loretta Nemchik1 insp.
Russell J Glapion1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Keystone Industries' 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