Company
United StatesPurdue Pharma L.P., Stamford, CT – FDA Inspections
Inspection records and compliance data for Purdue Pharma L.P. in Stamford, Connecticut. 8 FDA inspections on record, 3 Form 483s, last inspected October 05, 2023.
Company Profile
This profile covers Purdue Pharma L.P. based in Stamford, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected April 15, 2010. Last inspected October 5, 2023.
Most cited issue areas
- Failure to develop written procedures2 inspections
- Late submission of 15-day report2 inspections
- Failure to report non-alert ADEs1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 5, 2023 | VAI | Human Drugs · Bioresearch Monitoring | 1219674 |
| March 29, 2019 | VAI | Human Drugs · Bioresearch Monitoring | 1084657 |
| December 6, 2016 | Not classified | Human Drugs · Postmarket Surv. and Epidemiology | 994812 |
| July 28, 2016 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 979977 |
| July 6, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 979095 |
| May 25, 2012 | VAI | Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ | 783424 |
| April 15, 2011 | NAI | Human Drugs · Postmarket Surv. and Epidemiology | 719822 |
| April 15, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 659060 |
FDA documents
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Company Information
Name
Purdue Pharma L.P.
FEI Number
3004365793
Address
201 Tresser Blvd, Stamford, Connecticut 06901, United States
Country
United States
ID: 12a191f7-7216-4b7c-aa90-a6e20688a346