Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-20.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Dec 2023 – 20 Dec 2023 | Human Drugs | 483 | View 483 → |
| 4 Oct 2023 – 5 Oct 2023 | Foods & Cosmetics | Clean | |
| 23 Jan 2012 | Not recorded | 483 | On file |
| 18 Mar 2011 | Not recorded | 483 | View 483 → |
| 7 Jul 2010 | Not recorded | Clean | |
| 30 Sep 2009 | Not recorded | Clean | |
| 26 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Dec 2023
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Amatul H Marium
Investigators
FDA investigators tied to this site in the record.
Neil J Bonzagni2 insp.
Amatul H Marium1 insp.
Christine M Rivera1 insp.
Robert C Horan1 insp.
Alice S Tsao1 insp.
Thomas J Mooney1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Madcar Co Inc.'s 3 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