Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2015-09-23.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2015 – 23 Sep 2015 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Sep 2015
21 CFR 820.184
Lack of or inadequate DHR procedures
Cited by Lauren E Skokan Priest, Lauren E Skokan
23 Sep 2015
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Lauren E Skokan Priest, Lauren E Skokan
23 Sep 2015
21 CFR 820.70(i)
Software validation for automated processes
Cited by Lauren E Skokan Priest, Lauren E Skokan
23 Sep 2015
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Lauren E Skokan Priest, Lauren E Skokan
Investigators
FDA investigators tied to this site in the record.
Lauren E Skokan Priest1 insp.
Lauren E Skokan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | 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(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CrystalBraces, LLC.'s 1 Form 483
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