Company
United StatesAvadel Legacy Pharmaceuticals LLC, Chesterfield, MO – FDA Inspections
Inspection records and compliance data for Avadel Legacy Pharmaceuticals LLC in Chesterfield, Missouri. 8 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 24, 2019.
Company Profile
This profile covers Avadel Legacy Pharmaceuticals LLC based in Chesterfield, Missouri, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 1
- NAI
- 6
- Form 483s
- 1
- Warning letters
- 0
First inspected March 17, 2011. Last inspected April 24, 2019.
Most cited issue areas
- Failure to meet specifications1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 24, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1091059 |
| October 11, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1068774 |
| October 6, 2017 | NAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1027967 |
| September 23, 2015 | VAI | Human Drugs · Drug Quality Assurance | 946968 |
| December 9, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 859453 |
| November 2, 2011 | NAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 762688 |
| August 18, 2011 | NAI | Human Drugs · Drug Quality Assurance | 740214 |
| March 17, 2011 | OAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 715075 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Avadel Legacy Pharmaceuticals LLC
FEI Number
3008832322
Address
16640 Chesterfield Grove Rd Ste 200, Chesterfield, Missouri 63005, United States
Country
United States
ID: b4511df8-4278-4924-9a28-a3600d1fdc71