Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2008-10-30.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Oct 2008 | Not recorded | 483 | View 483 → |
| 30 Oct 2007 | Not recorded | Clean | |
| 16 Nov 2006 | Not recorded | Clean | |
| 23 Dec 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Authority lacking to review records, investigate errors
Cited by Annemarie Bodnar, Daniel J Grabicki
Procedures not in writing, fully followed
Cited by Annemarie Bodnar, Daniel J Grabicki
Reports of Analysis (Components)
Cited by Annemarie Bodnar, Daniel J Grabicki
Absence of Written Procedures
Cited by Annemarie Bodnar, Daniel J Grabicki
Scientifically sound laboratory controls
Cited by Annemarie Bodnar, Daniel J Grabicki
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 211.192 | 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 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(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 Medico Labs, 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