Atlas

Form 483

LEO Pharma Inc. Form 483, 2014-09-19

FDA issued a Form 483 to LEO Pharma Inc. on 2014-09-19 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

LEO Pharma Inc. · Parsippany, United States · Issued September 19, 2014

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.

19 Sep 2014
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Alberto A Viciedo

19 Sep 2014
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Alberto A Viciedo

Inspected site

LPLEO Pharma Inc.Parsippany, United States

Inspection team

AAAlberto A Viciedo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)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