Atlas

Form 483

Bial Portela & Ca., S.A. Form 483, 2024-06-21

FDA issued a Form 483 to Bial Portela & Ca., S.A. on 2024-06-21 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Bial Portela & Ca., S.A. · South Mamede Do Coronado, Portugal · Issued June 21, 2024

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

BPBial Portela & Ca., S.A.South Mamede Do Coronado, Portugal

Inspection team

DADavid A Oluwo
KHKenneth H Williams

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere