Atlas

Form 483

Mitsubishi Tanabe Pharma America, Inc. Form 483, 2013-12-04

FDA issued a Form 483 to Mitsubishi Tanabe Pharma America, Inc. on 2013-12-04 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Mitsubishi Tanabe Pharma America, Inc. · Jersey City, United States · Issued December 4, 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.

4 Dec 2013
21 CFR 312.50

General responsibilities of sponsors

Cited by Christina N Maurino

Inspected site

MTMitsubishi Tanabe Pharma America, Inc.Jersey City, United States

Inspection team

CNChristina N Maurino

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited 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