Atlas

Form 483

B. Braun Surgical, S.A. Form 483, 2014-03-20

FDA issued a Form 483 to B. Braun Surgical, S.A. on 2014-03-20 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

B. Braun Surgical, S.A. · Rubi, Spain · Issued March 20, 2014

Overview

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

Inspectional observations

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

20 Mar 2014
21 CFR 803.18(e)

MDR not evaluated per 820.162 and 820.198

Cited by Ronald Ifraimov

20 Mar 2014
21 CFR 820.198(a)

Complaints

Cited by Ronald Ifraimov

Inspected site

BBB. Braun Surgical, S.A.Rubi, Spain

Inspection team

RIRonald Ifraimov

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.18(e)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, 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