Atlas

Form 483

Pt Ciba Vision Batam Form 483, 2022-08-26

FDA issued a Form 483 to Pt Ciba Vision Batam on 2022-08-26 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Pt Ciba Vision Batam · Batam Island, Indonesia · Issued August 26, 2022

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

26 Aug 2022
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by John A Sciacchitano

26 Aug 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by John A Sciacchitano

26 Aug 2022
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by John A Sciacchitano

Inspected site

PCPt Ciba Vision BatamBatam Island, Indonesia

Inspection team

JAJohn A Sciacchitano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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