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Form 483

Sunstar Americas, Inc. Form 483, 2023-02-10

FDA issued a Form 483 to Sunstar Americas, Inc. on 2023-02-10 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Sunstar Americas, Inc. · Schaumburg, United States · Issued February 10, 2023

Overview

  • 1 public-safe observation is 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.

10 Feb 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Amanda Dinaro

Inspected site

SASunstar Americas, Inc.Schaumburg, United States

Inspection team

ADAmanda Dinaro

Cited regulations

CFR citations associated with this Form 483.

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

Source document

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Form 483 source document

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  • 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