Atlas

Form 483

Sugih Instrumendo Abadi, PT. Form 483, 2023-11-02

FDA issued a Form 483 to Sugih Instrumendo Abadi, PT. on 2023-11-02 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Sugih Instrumendo Abadi, PT. · Padalarang, Jawa Barat, Indonesia · Issued November 2, 2023

Overview

  • 4 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.

2 Nov 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Dawn M Braswell

2 Nov 2023
21 CFR 820.184

DHR content

Cited by Dawn M Braswell

2 Nov 2023
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Dawn M Braswell

2 Nov 2023
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Dawn M Braswell

Inspected site

SISugih Instrumendo Abadi, PT.Padalarang, Jawa Barat, Indonesia

Inspection team

DMDawn M Braswell

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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