Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-05-20.
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 |
|---|---|---|---|
| 9 May 2022 – 20 May 2022 | Human Drugs | 483 | View 483 → |
| 2 Dec 2019 – 6 Dec 2019 | Human Drugs | 483 | On file |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | Clean | |
| 17 Nov 2015 – 20 Nov 2015 | Human Drugs | Clean | |
| 18 Jun 2013 – 25 Jun 2013 | Human Drugs | Clean | |
| 29 Jul 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 May 2022
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Nicole E Knowlton, Rafeeq A Habeeb
20 May 2022
21 CFR 211.48(a)
Potable water standards not met
Cited by Nicole E Knowlton, Rafeeq A Habeeb
20 May 2022
21 CFR 211.63
Equipment Design, Size and Location
Cited by Nicole E Knowlton, Rafeeq A Habeeb
Investigators
FDA investigators tied to this site in the record.
Rafael Nevarez Nieves2 insp.
Ana P Pineda Zavaleta2 insp.
Nicole E Knowlton1 insp.
Rafeeq A Habeeb1 insp.
Tamil Arasu1 insp.
Reba A Gates1 insp.
Jose E Melendez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.48(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BOEHRINGER INGELHEIM PROMECO S.A. de C.V.'s 2 Form 483s
Source PDFs 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