Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2009-04-08.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2009 | Not recorded | 483 | View 483 → |
| 30 Mar 2009 | Not recorded | Clean | |
| 12 Jun 2008 | Not recorded | 483 | On file |
| 5 May 2008 | Not recorded | Clean | |
| 30 Nov 2006 | Not recorded | Clean | |
| 13 Oct 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Apr 2009
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Dongping Dai, Uduak M Inokon, Gary J Lehr
8 Apr 2009
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Dongping Dai, Uduak M Inokon, Gary J Lehr
8 Apr 2009
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Dongping Dai, Uduak M Inokon, Gary J Lehr
8 Apr 2009
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Dongping Dai, Uduak M Inokon, Gary J Lehr
8 Apr 2009
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Dongping Dai, Uduak M Inokon, Gary J Lehr
Investigators
FDA investigators tied to this site in the record.
Dongping Dai1 insp.
Uduak M Inokon1 insp.
Gary J Lehr1 insp.
State Agency1 insp.
Joy P Matthias1 insp.
James A Liubicich1 insp.
Cntrctmntr Smithson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(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(e) | 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)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | 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 Corwood Labs Inc's 2 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