Company
United StatesScholten Surgical Instruments, Lodi, CA – FDA Inspections
Inspection records and compliance data for Scholten Surgical Instruments in Lodi, California. 2 FDA inspections on record, last inspected December 05, 2014.
Company Profile
This profile covers Scholten Surgical Instruments based in Lodi, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 21, 2010. Last inspected December 5, 2014.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Documentation of disposition, justification, signature1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 5, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 904917 |
| January 21, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 642925 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Scholten Surgical Instruments
FEI Number
2936330
Address
170 Commerce St Ste 101, Lodi, California 95240, United States
Country
United States
ID: 8fcd04f7-b69c-4a6c-aa5a-75cd7487f369