Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-20.
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 |
|---|---|---|---|
| 12 Feb 2020 – 20 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Feb 2014 – 26 Feb 2014 | Medical Devices & Rad Health | Clean | |
| 31 Aug 2011 | Not recorded | 483 | View 483 → |
| 14 Jul 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Feb 2020
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Marlo I Alintanahin, Marlo-Ian M Alintanahin
20 Feb 2020
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Marlo I Alintanahin, Marlo-Ian M Alintanahin
20 Feb 2020
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Marlo I Alintanahin, Marlo-Ian M Alintanahin
20 Feb 2020
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Marlo I Alintanahin, Marlo-Ian M Alintanahin
20 Feb 2020
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Marlo I Alintanahin, Marlo-Ian M Alintanahin
Investigators
FDA investigators tied to this site in the record.
Marlo I Alintanahin1 insp.
Marlo-Ian M Alintanahin1 insp.
Vickie L Anderson1 insp.
Binh T Nguyen1 insp.
William S Vitale1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bio Protech Usa, Inc.'s 3 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