Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-09-29.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Sep 2017 – 29 Sep 2017 | Human Drugs | Clean | |
| 24 Nov 2014 – 28 Nov 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Nov 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jessica L Pressley, Ann M Stewart
28 Nov 2014
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Jessica L Pressley, Ann M Stewart
28 Nov 2014
21 CFR 211.165(a)
Testing and release for distribution
Cited by Jessica L Pressley, Ann M Stewart
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 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Shandex Personal Care Manufacturing Inc.'s 1 Form 483
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