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Form 483

ESPERION THERAPEUTICS INC Form 483, 2019-08-09

FDA issued a Form 483 to ESPERION THERAPEUTICS INC on 2019-08-09 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

ESPERION THERAPEUTICS INC · Ann Arbor, United States · Issued August 9, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Aug 2019
21 CFR 312.50

General responsibilities of sponsors

Cited by Myra K Casey, Camille D Brown

9 Aug 2019
21 CFR 312.50

General responsibilities of sponsors

Cited by Myra K Casey, Camille D Brown

Inspected site

ETESPERION THERAPEUTICS INCAnn Arbor, United States

Inspection team

MKMyra K Casey
CDCamille D Brown

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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