Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-21.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jun 2024 – 21 Jun 2024 | Human Drugs | 483 | View 483 → |
| 6 May 2019 – 10 May 2019 | Human Drugs | Clean | |
| 9 Nov 2015 – 12 Nov 2015 | Human Drugs | 483 | On file |
| 12 Dec 2012 | Not recorded | Clean | |
| 15 Sep 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jun 2024
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by David A Oluwo, Kenneth H Williams
21 Jun 2024
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by David A Oluwo, Kenneth H Williams
Investigators
FDA investigators tied to this site in the record.
David A Oluwo1 insp.
Kenneth H Williams1 insp.
MRA DavisM1 insp.
Robert J Martin1 insp.
Eric M Mueller1 insp.
Burnell M Henry1 insp.
Charisse K Green1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | 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 Bial Portela & Ca., S.A.'s 2 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