Form 483

Aptyx Charlotte, LLC Form 483, 2016-03-21

FDA issued a Form 483 to Aptyx Charlotte, LLC on 2016-03-21 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Aptyx Charlotte, LLC · Charlotte, United States · Issued March 21, 2016

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.

21 Mar 2016
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Gamal A Norton

Inspected site

ACAptyx Charlotte, LLCCharlotte, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations1x

Full 483 report

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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