Atlas

Form 483

Regeneron Pharmaceuticals, Inc. Form 483, 2016-08-19

FDA issued a Form 483 to Regeneron Pharmaceuticals, Inc. on 2016-08-19 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Regeneron Pharmaceuticals, Inc. · Rensselaer, United States · Issued August 19, 2016

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.

19 Aug 2016
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Robert C Horan

Inspected site

RPRegeneron Pharmaceuticals, Inc.Rensselaer, United States

Inspection team

RCRobert C Horan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

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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