Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-09-19.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2014 – 19 Sep 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Aug 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Sep 2014
21 CFR 820.20(a)
Management ensuring quality policy is understood
Cited by Dawn M Braswell, Claudette D Brooks
19 Sep 2014
21 CFR 820.22
Quality Audit/Reaudit - conducted
Cited by Dawn M Braswell, Claudette D Brooks
19 Sep 2014
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Dawn M Braswell, Claudette D Brooks
19 Sep 2014
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Dawn M Braswell, Claudette D Brooks
19 Sep 2014
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Dawn M Braswell, Claudette D Brooks
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind G3 Medical, Inc. dba G3 Packaging's 2 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