Form 483

Merck & Co. Inc Form 483, 2019-09-06

FDA issued a Form 483 to Merck & Co. Inc on 2019-09-06 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Merck & Co. Inc · Rahway, United States · Issued September 6, 2019

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.

6 Sep 2019
21 CFR 312.56(b)

Notification of FDA of termination of investigator

Cited by Peter R Lenahan

Inspected site

M&Merck & Co. IncRahway, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.56(b)Cited across public-safe Form 483 observations1x

Full 483 report

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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