Atlas

Form 483

Sumitomo Pharma America, Inc. Form 483, 2015-01-23

FDA issued a Form 483 to Sumitomo Pharma America, Inc. on 2015-01-23 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Sumitomo Pharma America, Inc. · Marlborough, United States · Issued January 23, 2015

Overview

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

Inspectional observations

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

23 Jan 2015
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by John P Mistler, Erik W Koester, Stacey S Degarmo

Inspected site

SPSumitomo Pharma America, Inc.Marlborough, United States

Inspection team

JPJohn P Mistler
EWErik W Koester
SSStacey S Degarmo

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

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