Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-10-21.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Oct 2015 – 21 Oct 2015 | Human Drugs | Clean | |
| 27 Jun 2013 – 22 Jul 2013 | Human Drugs | 483 | View 483 → |
| 18 Apr 2012 | Not recorded | 483 | View 483 → |
| 22 Nov 2010 | Not recorded | 483 | View 483 → |
| 12 Nov 2008 | Not recorded | WL | View 483 → |
| 1 Oct 2008 | Not recorded | 483 | On file |
| 28 Mar 2003 | Not recorded | Clean | |
| 18 Sep 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jul 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose E Melendez, Frances L Dejesus
22 Jul 2013
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Jose E Melendez, Frances L Dejesus
22 Jul 2013
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Jose E Melendez, Frances L Dejesus
18 Apr 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Rafael Gonzalez, Dayna I Martinez
Investigators
FDA investigators tied to this site in the record.
Rebecca Parrilla2 insp.
German Rivera1 insp.
Jose E Melendez1 insp.
Frances L Dejesus1 insp.
Rafael Gonzalez1 insp.
Dayna I Martinez1 insp.
Jorge L Lajara1 insp.
Milva E Melendez1 insp.
Brenda Rivera1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Olay LLC's 5 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