Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-03.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jul 2024 – 3 Sep 2024 | Human Drugs | 483 | On file |
| 14 Jun 2023 – 29 Sep 2023 | Human Drugs | 483 | On file |
| 6 Jul 2021 – 28 Jul 2021 | Human Drugs | WL | On file |
| 20 Feb 2018 | Foods & Cosmetics | Clean | |
| 26 Sep 2016 – 6 Oct 2016 | Foods & Cosmetics | 483 | View 483 → |
| 1 Apr 2013 – 5 Apr 2013 | Human Drugs | 483 | View 483 → |
| 5 Apr 2012 | Not recorded | 483 | View 483 → |
| 26 Mar 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Oct 2016
21 CFR 111.113(a)(2)
QC master manufacturing record; material review, disposition
Cited by Helen J Hamaoka
6 Oct 2016
21 CFR 111.210(a)
Master manufacturing record - dietary ingredients
Cited by Helen J Hamaoka
Investigators
FDA investigators tied to this site in the record.
John A Gonzalez3 insp.
Siobhan A Gallagher1 insp.
Helen J Hamaoka1 insp.
Thomas W Gordon1 insp.
Stuart W Russell1 insp.
Uduak M Inokon1 insp.
Joanne M Fukuda1 insp.
Daniel J Roberts1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.35(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.113(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(B) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.95(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.95(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | 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)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | 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(a) | 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(a) | 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 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Generitech Corporation'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