Atlas

Form 483

MDI East Inc., DBA Aptyx Form 483, 2014-07-23

FDA issued a Form 483 to MDI East Inc., DBA Aptyx on 2014-07-23 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

MDI East Inc., DBA Aptyx · South Glens Falls, United States · Issued July 23, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

23 Jul 2014
21 CFR 820.70(g)(1)

Maintenance schedule, Lack of or inadequate schedule

Cited by Meisha A Mandal

23 Jul 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Meisha A Mandal

Inspected site

MEMDI East Inc., DBA AptyxSouth Glens Falls, United States

Inspection team

MAMeisha A Mandal

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(g)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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