Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-26.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 May 2026 – 26 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jun 2023 – 21 Jun 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Apr 2017 – 27 Apr 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Aug 2013 – 28 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2011 | Not recorded | Clean | |
| 28 Jul 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2026
ISO 13485:2016 Clause 6.1(a)
Resources for quality management system have not been determined or provided
Cited by Katarzyna Plona
26 May 2026
ISO 13485:2016 Clause 6.1(a)
Resources for quality management system have not been determined or provided
Cited by Katarzyna Plona
26 May 2026
ISO 13485:2016 Clause 7.4.3
Purchased product verification activities not established or implemented
Cited by Katarzyna Plona
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 820.20(c) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 6.1(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.4.3 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biowave Corporation's 5 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