Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-05-25.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 May 2018 – 25 May 2018 | Human Drugs | 483 | View 483 → |
| 25 Jul 2016 – 29 Jul 2016 | Human Drugs | 483 | View 483 → |
| 12 May 2014 – 16 May 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
25 May 2018
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Nicholas L Hunt
29 Jul 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Maria P Kelly-Doggett
Investigators
FDA investigators tied to this site in the record.
Nicholas L Hunt1 insp.
Maria P Kelly-Doggett1 insp.
Rafael Nevarez Nieves1 insp.
Ana P Pineda Zavaleta1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | 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 Farmaqro, S.A. de C.V.'s 3 Form 483s
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