Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-09.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Apr 2026 – 9 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Dec 2022 – 15 Dec 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Mar 2016 – 23 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 9 Dec 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Apr 2026
ISO 13485:2016 Clause 6.4.1(a)
Requirements for personnel health, cleanliness, and clothing not documented
Cited by Naakesh N Gomanie
9 Apr 2026
ISO 13485:2016 Clause 7.5.7
Processes for sterilization and sterile barrier systems not validated
Cited by Naakesh N Gomanie
9 Apr 2026
ISO 13485:2016 Clause 8.2.5
Monitoring/measurement methods do not show QMS processes meet planned results
Cited by Naakesh N Gomanie
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 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.1(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.5 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bio Protech, Inc.'s 3 Form 483s
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