Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-04-25.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Apr 2023 – 25 Apr 2023 | Biologics | 483 | View 483 → |
| 11 Nov 2019 – 15 Nov 2019 | Biologics | Clean | |
| 26 Sep 2016 – 29 Sep 2016 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Apr 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Scott T Ballard, Creighton T Tuzon
25 Apr 2023
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Scott T Ballard, Creighton T Tuzon
25 Apr 2023
21 CFR 820.70(g)
Equipment design and installation
Cited by Scott T Ballard, Creighton T Tuzon
25 Apr 2023
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Scott T Ballard, Creighton T Tuzon
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 820.100(a) | 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(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fenwal International, Inc.'s 1 Form 483
Source PDFs 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