Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-07-15.
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 |
|---|---|---|---|
| 11 Jul 2016 – 15 Jul 2016 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jul 2016
21 CFR 211.192
Written record of investigation incomplete
Cited by Santos E Camara, Caroline Strasinger
15 Jul 2016
21 CFR 211.42(c)(9)
Control / Lab Operations Area
Cited by Santos E Camara, Caroline Strasinger
15 Jul 2016
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Santos E Camara, Caroline Strasinger
15 Jul 2016
21 CFR 211.68(b)
Computer control of master formula records
Cited by Santos E Camara, Caroline Strasinger
Investigators
FDA investigators tied to this site in the record.
Santos E Camara1 insp.
Caroline Strasinger1 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 | 1x |
| 21 CFR 211.42(c)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bayer de Mexico, S.A. de C.V.'s 1 Form 483
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