Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-07-19.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jul 2019 – 19 Jul 2019 | Human Drugs | 483 | On file |
| 6 Nov 2015 – 17 Nov 2015 | Human Drugs | 483 | View 483 → |
| 30 Mar 2011 | Not recorded | Clean | |
| 2 Oct 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Nov 2015
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Massoud Motamed, Shelby N Marler, Matthew R Maddox
17 Nov 2015
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Massoud Motamed, Shelby N Marler, Matthew R Maddox
17 Nov 2015
21 CFR 211.204
Record information inclusions
Cited by Massoud Motamed, Shelby N Marler, Matthew R Maddox
Investigators
FDA investigators tied to this site in the record.
Vilmary Negron Rodriguez1 insp.
Massoud Motamed1 insp.
Shelby N Marler1 insp.
Matthew R Maddox1 insp.
Cntrctmntr Martinez1 insp.
Scott T Ballard1 insp.
Jodi M Gatica1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Mary Kay, Inc's 2 Form 483s
Source PDFs 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