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Form 483

Sumitomo Pharma America, Inc. Form 483, 2013-05-24

FDA issued a Form 483 to Sumitomo Pharma America, Inc. on 2013-05-24 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Sumitomo Pharma America, Inc. · Marlborough, United States · Issued May 24, 2013

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

24 May 2013
21 CFR 312.50

General responsibilities of sponsors

Cited by Kent A Conforti, Matthew C Watson

Inspected site

SPSumitomo Pharma America, Inc.Marlborough, United States

Inspection team

KAKent A Conforti
MCMatthew C Watson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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  • 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