Company
United StatesEtymotic Research, Inc., Schaumburg, IL – FDA Inspections
Inspection records and compliance data for Etymotic Research, Inc. in Schaumburg, Illinois. 5 FDA inspections on record, 1 Form 483, last inspected August 14, 2019.
Company Profile
This profile covers Etymotic Research, Inc. based in Schaumburg, Illinois, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 15, 2009. Last inspected August 14, 2019.
Most cited issue areas
- Changes to correct/prevent quality problems1 inspection
- DHR content - manufacturing dates1 inspection
- General1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 14, 2019 | Not classified | Medical Devices & Rad Health | 1143528 |
| November 2, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1031757 |
| September 9, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 900647 |
| March 2, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 650786 |
| July 15, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 603528 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Etymotic Research, Inc.
FEI Number
1450042
Address
1125 Remington Rd, Schaumburg, Illinois 60173-4809, United States
Country
United States
ID: ae8e56f7-8297-4039-b8fb-941891b18f82