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.
30 Oct 2008
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Annemarie Bodnar, Daniel J Grabicki
30 Oct 2008
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Annemarie Bodnar, Daniel J Grabicki
30 Oct 2008
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Annemarie Bodnar, Daniel J Grabicki
30 Oct 2008
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Annemarie Bodnar, Daniel J Grabicki
30 Oct 2008
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Annemarie Bodnar, Daniel J Grabicki
Investigators
FDA investigators tied to this site in the record.
Annemarie Bodnar1 insp.
Daniel J Grabicki1 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 211.100(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