Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-03-22.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Mar 2018 – 22 Mar 2018 | Medical Devices & Rad Health | 483 | On file |
| 15 Apr 2015 – 23 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Jun 2013 – 14 Jun 2013 | Medical Devices & Rad Health | Clean | |
| 7 Oct 2010 | Not recorded | Clean | |
| 12 Jun 2009 | Not recorded | 483 | View 483 → |
| 10 May 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Apr 2015
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Sargum C Sood, Cynthia L Aycock, Cynthia Li
23 Apr 2015
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Sargum C Sood, Cynthia L Aycock, Cynthia Li
23 Apr 2015
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Sargum C Sood, Cynthia L Aycock, Cynthia Li
23 Apr 2015
21 CFR 820.50(b)
Supplier notification of changes
Cited by Sargum C Sood, Cynthia L Aycock, Cynthia Li
23 Apr 2015
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Sargum C Sood, Cynthia L Aycock, Cynthia Li
Investigators
FDA investigators tied to this site in the record.
MDSAP WilliamsA1 insp.
Sargum C Sood1 insp.
Cynthia L Aycock1 insp.
Cynthia Li1 insp.
Deanna L Lampley1 insp.
Tracey L Siebesma1 insp.
Brian J Mundo1 insp.
Ryan J Benedict1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Becker Orthopedic Appliance Co.'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