Atlas

FDA-Inspected Site

Sumitomo Pharma America, Inc.

11 FDA inspections are on record for Sumitomo Pharma America, Inc. in Marlborough, United States.

Clean· No action indicated

Marlborough, United States · Last updated July 11, 2026

Overview

  • 11 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-08-02.

At a glance

Inspections

11

Form 483s

6

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Jul 2024 – 2 Aug 2024Human DrugsClean
16 Nov 2021 – 18 Nov 2021Human DrugsClean
1 Nov 2021 – 5 Nov 2021Human DrugsClean
15 Jan 2015 – 23 Jan 2015Human Drugs483View 483 →
24 Apr 2013 – 24 May 2013Human Drugs483View 483 →
9 Dec 2011Not recorded483View 483 →
20 Apr 2011Not recorded483View 483 →
3 Jun 2010Not recorded483View 483 →
20 Oct 2009Not recordedClean
1 Sep 2009Not recorded483View 483 →
12 Nov 2004Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

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

24 May 2013
21 CFR 312.50

General responsibilities of sponsors

Cited by Kent A Conforti, Matthew C Watson

9 Dec 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Philip Kreiter

9 Dec 2011
21 CFR 314.81(b)(1)(ii)

Contamination, chemical or physical change, deterioration

Cited by Philip Kreiter

20 Apr 2011
21 CFR 211.22(a)

Contract drug products--lack of responsibility

Cited by Stacey S Degarmo, Amy C Jordan

Investigators

FDA investigators tied to this site in the record.

Stacey S Degarmo3 insp.
Kent A Conforti2 insp.
Victoria M Daddeo2 insp.
Darin S Wiegers2 insp.
Amy C Jordan2 insp.
John P Mistler1 insp.
Erik W Koester1 insp.
Matthew C Watson1 insp.
Philip Kreiter1 insp.
Mary-Jeanet Mcgarry1 insp.
John S Hartford1 insp.
Leo B Zadecky1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations2x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 312.50Cited across public-safe Form 483 observations1x
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
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sumitomo Pharma America, Inc.'s 6 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat