Company
United StatesSumitomo Pharma America, Inc., Marlborough, MA – FDA Inspections
Inspection records and compliance data for Sumitomo Pharma America, Inc. in Marlborough, Massachusetts. 9 FDA inspections on record, last inspected August 02, 2024.
Company Profile
This profile covers Sumitomo Pharma America, Inc. based in Marlborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 5
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected September 1, 2009. Last inspected August 2, 2024.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Contamination, chemical or physical change, deterioration1 inspection
- General responsibilities of sponsors1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1242239 |
| November 5, 2021 | NAI | Human Drugs · Bioresearch Monitoring | 1161579 |
| January 23, 2015 | VAI | Human Drugs · Bioresearch Monitoring | 915063 |
| May 24, 2013 | VAI | Human Drugs · Bioresearch Monitoring | 843011 |
| December 9, 2011 | VAI | Human Drugs · Drug Quality Assurance | 759431 |
| April 20, 2011 | NAI | Human Drugs · Bioresearch Monitoring | 723394 |
| June 3, 2010 | VAI | Human Drugs · Drug Quality Assurance | 668170 |
| October 20, 2009 | NAI | Human Drugs · Bioresearch Monitoring | 621672 |
| September 1, 2009 | VAI | Human Drugs · Bioresearch Monitoring | 608872 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sumitomo Pharma America, Inc.
FEI Number
1222021
Address
84 Waterford Dr, Marlborough, Massachusetts 01752, United States
Country
United States
ID: f5f01b1a-a43a-478e-a89c-f2d7c3003136