Company
United StatesMyolyn Inc., Gainesville, FL – FDA Inspections
Inspection records and compliance data for Myolyn Inc. in Gainesville, Florida. 1 FDA inspection on record, 1 Form 483, last inspected September 14, 2018.
Company Profile
This profile covers Myolyn Inc. 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 September 14, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - software validation not performed1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 14, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1065812 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Myolyn Inc.
FEI Number
3013503259
Address
6931 Nw 22nd St Ste A, Gainesville, Florida 32653, United States
Country
United States
ID: 650b54fb-cd08-4448-9682-4afd1466b24d