Company
United StatesBiomonde US, LLC, Gainesville, FL – FDA Inspections
Inspection records and compliance data for Biomonde US, LLC in Gainesville, Florida. 1 FDA inspection on record, 1 Form 483, last inspected November 17, 2017.
Company Profile
This profile covers Biomonde US, LLC based in Gainesville, Florida, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected November 17, 2017.
Most cited issue areas
- Design history file1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1032463 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomonde US, LLC
FEI Number
3011126619
Address
747 Sw 2nd Ave Ste 240, Gainesville, Florida 32601, United States
Country
United States
ID: fa823d17-b0ef-4428-8b5c-839f375d9880