Atlas

Form 483

CASCINATION Form 483, 2018-06-14

FDA issued a Form 483 to CASCINATION on 2018-06-14 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

CASCINATION · Bern, Switzerland · Issued June 14, 2018

Overview

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

Inspectional observations

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

14 Jun 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Kathleen S Tormey

14 Jun 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Kathleen S Tormey

14 Jun 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Kathleen S Tormey

14 Jun 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Kathleen S Tormey

14 Jun 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Kathleen S Tormey

Inspected site

CCASCINATIONBern, Switzerland

Inspection team

KSKathleen S Tormey

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations5x

Full 483 report

Get the verbatim text of all 5 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