Company
United StatesW. L. Gore & Associates, Inc., Santa Clara, CA – FDA Inspections
Inspection records and compliance data for W. L. Gore & Associates, Inc. in Santa Clara, California. 2 FDA inspections on record, 1 Form 483, last inspected March 21, 2019.
Company Profile
This profile covers W. L. Gore & Associates, Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 11, 2017. Last inspected March 21, 2019.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Process changes - review, evaluation and revalidation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 21, 2019 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1083404 |
| January 11, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 997735 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
W. L. Gore & Associates, Inc.
FEI Number
3013164176
Address
2890 De La Cruz Blvd, Santa Clara, California 95050, United States
Country
United States
ID: 31753c95-f500-4cb9-8984-9a75c3ab3c81