Atlas

Form 483

Merck & Co. Inc Form 483, 2015-02-23

FDA issued a Form 483 to Merck & Co. Inc on 2015-02-23 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Merck & Co. Inc · Rahway, United States · Issued February 23, 2015

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 Feb 2015
21 CFR 312.50

General responsibilities of sponsors

Cited by Jonee J Mearns

23 Feb 2015
21 CFR 312.58(a)

FDA access to sponsor records

Cited by Jonee J Mearns

Inspected site

M&Merck & Co. IncRahway, United States

Inspection team

JJJonee J Mearns

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 312.58(a)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