Company
United StatesEdwards Lifesciences Technology SARL, Anasco, PR – FDA Inspections
Inspection records and compliance data for Edwards Lifesciences Technology SARL in Anasco, Puerto Rico. 4 FDA inspections on record, 1 Form 483, last inspected June 11, 2019.
Company Profile
This profile covers Edwards Lifesciences Technology SARL based in Anasco, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 15, 2010. Last inspected June 11, 2019.
Most cited issue areas
- Actual vs. theoretical yields not determined1 inspection
- Annual visual exams of drug products1 inspection
- Documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 11, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1093287 |
| March 24, 2017 | Not classified | Medical Devices & Rad Health | 1018411 |
| January 27, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 911643 |
| April 15, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 657755 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Edwards Lifesciences Technology SARL
FEI Number
2648045
Address
Hwy # 402 North, Km 1.4, Anasco, Puerto Rico 00610, United States
Country
United States
ID: 42a7d334-7d45-4aef-8eef-d3a28ee5ded6