Company
United StatesSgarlato Med, LLC, San Jose, CA – FDA Inspections
Inspection records and compliance data for Sgarlato Med, LLC in San Jose, California. 3 FDA inspections on record (1 OAI), last inspected December 19, 2014.
Company Profile
This profile covers Sgarlato Med, LLC based in San Jose, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected April 5, 2010. Last inspected December 19, 2014.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate receiving acceptance procedures2 inspections
- Quality Audit/Reaudit - conducted2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 19, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 907533 |
| December 29, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 697188 |
| April 5, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 660118 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sgarlato Med, LLC
FEI Number
2939320
Address
1975 Hamilton Ave Ste 38, San Jose, California 95125, United States
Country
United States
ID: ba562ee3-a114-4e00-a18d-3885d66d0d4d