Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-09-27.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2022 – 27 Sep 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Aug 2017 – 23 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 24 Oct 2016 – 28 Oct 2016 | Medical Devices & Rad Health | Clean | |
| 5 Apr 2013 – 12 Apr 2013 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Sep 2022
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Frank J Marciniak
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 820.184 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(h) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 4x |
Full site report
Get the verbatim findings behind Alfa Wassermann, 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