FDA-Inspected Site

B. Braun Surgical, S.A.

3 FDA inspections are on record for B. Braun Surgical, S.A. in Rubi, Spain.

Clean· No action indicated

Rubi, Spain · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-26.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Mar 2026 – 26 Mar 2026Medical Devices & Rad HealthClean
22 May 2018 – 25 May 2018Medical Devices & Rad Health483On file
17 Mar 2014 – 20 Mar 2014Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

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

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

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 site report

Get the verbatim findings behind B. Braun Surgical, S.A.'s 2 Form 483s

Verbatim observations 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