Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2010-11-04.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Nov 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2010
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Jodi M Gatica
4 Nov 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jodi M Gatica
4 Nov 2010
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Jodi M Gatica
4 Nov 2010
21 CFR 211.25(b)
Supervisor Training/Education/Experience
Cited by Jodi M Gatica
4 Nov 2010
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Jodi M Gatica
Investigators
FDA investigators tied to this site in the record.
Jodi M Gatica1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | 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 |
| 21 CFR 211.25(b) | 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 this site'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