Atlas

Form 483

Lantheus Medical Imaging, Inc. Form 483, 2013-06-20

FDA issued a Form 483 to Lantheus Medical Imaging, Inc. on 2013-06-20 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Lantheus Medical Imaging, Inc. · North Billerica, United States · Issued June 20, 2013

Overview

  • 2 public-safe observations are 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.

20 Jun 2013
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Edmund F Mrak

20 Jun 2013
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Edmund F Mrak

Inspected site

LMLantheus Medical Imaging, Inc.North Billerica, United States

Inspection team

EFEdmund F Mrak

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x

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