Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-03-24.
At a glance
Inspections
5
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Mar 2021 – 24 Mar 2021 | Human Drugs | 483 | View 483 → |
| 17 Mar 2015 – 27 Mar 2015 | Human Drugs | 483 | View 483 → |
| 19 Aug 2013 – 30 Aug 2013 | Human Drugs | 483 | View 483 → |
| 9 Jul 2010 | Not recorded | 483 | On file |
| 11 Apr 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Mar 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Anastasia M Shields, Michele Gottshall
27 Mar 2015
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by James M Mason, Thomas E Friel, Rabin N Ghoshal
27 Mar 2015
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by James M Mason, Thomas E Friel, Rabin N Ghoshal
30 Aug 2013
21 CFR 211.192
Investigations of discrepancies, failures
Cited by James M Mason, Karen E Dorazio
Investigators
FDA investigators tied to this site in the record.
James M Mason2 insp.
Anastasia M Shields1 insp.
Michele Gottshall1 insp.
Thomas E Friel1 insp.
Rabin N Ghoshal1 insp.
Karen E Dorazio1 insp.
Anita R Michael1 insp.
Sharon K Thoma1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Johnson & Johnson Consumer, Inc's 4 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