Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-28.
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 |
|---|---|---|---|
| 24 Oct 2022 – 28 Oct 2022 | Human Drugs | 483 | View 483 → |
| 13 Feb 2017 – 15 Feb 2017 | Human Drugs | 483 | On file |
| 9 Nov 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Oct 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Christopher M Jenner, Tiara M Brown
28 Oct 2022
21 CFR 211.160(b)(1)
Samples (various types) representative, identified properly
Cited by Christopher M Jenner, Tiara M Brown
28 Oct 2022
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Christopher M Jenner, Tiara M Brown
Investigators
FDA investigators tied to this site in the record.
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 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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 Broncolin, S.A. de C.V.'s 3 Form 483s
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