Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-10-07.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Oct 2015 – 7 Oct 2015 | Medical Devices & Rad Health | Clean | |
| 10 Nov 2014 – 25 Nov 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Feb 2012 | Not recorded | 483 | View 483 → |
| 18 Oct 2010 | Not recorded | 483 | View 483 → |
| 4 Feb 2009 | Not recorded | 483 | On file |
| 29 Jul 2005 | Not recorded | Clean | |
| 6 Jun 2002 | Not recorded | Clean | |
| 5 May 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Nov 2014
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by Cynthia L Aycock, Thomas A Peter, Cynthia Li
25 Nov 2014
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Cynthia L Aycock, Thomas A Peter, Cynthia Li
25 Nov 2014
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Cynthia L Aycock, Thomas A Peter, Cynthia Li
25 Nov 2014
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Cynthia L Aycock, Thomas A Peter, Cynthia Li
25 Nov 2014
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
Cited by Cynthia L Aycock, Thomas A Peter, Cynthia Li
Investigators
FDA investigators tied to this site in the record.
Cynthia L Aycock2 insp.
Thomas A Peter1 insp.
Cynthia Li1 insp.
Brian P Putz1 insp.
Deanna L Lampley1 insp.
Ryan J Benedict1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | 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 BioPro, Inc.'s 4 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