Atlas

Form 483

Regeneron Pharmaceuticals Inc Form 483, 2013-02-22

FDA issued a Form 483 to Regeneron Pharmaceuticals Inc on 2013-02-22 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Regeneron Pharmaceuticals Inc · Tarrytown, United States · Issued February 22, 2013

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.

22 Feb 2013
21 CFR 600.80(b)

Review of Adverse Experiences - SOPs

Cited by Paul C Mouris

Inspected site

RPRegeneron Pharmaceuticals IncTarrytown, United States

Inspection team

PCPaul C Mouris

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 600.80(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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