Company
United StatesKarl Storz Endoscopy America Inc, Auburn, MA – FDA Inspections
Inspection records and compliance data for Karl Storz Endoscopy America Inc in Auburn, Massachusetts. 5 FDA inspections on record, 1 Form 483, last inspected February 15, 2024.
Company Profile
This profile covers Karl Storz Endoscopy America Inc based in Auburn, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 5, 2010. Last inspected February 15, 2024.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Documentation1 inspection
- Records, DHR {see also 820.184(e)}1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 15, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1230647 |
| May 24, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1170790 |
| June 4, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1093439 |
| January 10, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 998085 |
| January 5, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 642593 |
FDA documents
Form 483s (1)
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Company Information
Name
Karl Storz Endoscopy America Inc
FEI Number
2020550
Address
28 Millbury St, Auburn, Massachusetts 01501, United States
Country
United States
ID: f4a4bea6-c1cf-4659-9467-fa744b85b08a