Company
United StatesOSKO, Inc., Medley, FL – FDA Inspections
Inspection records and compliance data for OSKO, Inc. in Medley, Florida. 2 FDA inspections on record (1 OAI), 2 Form 483s, last inspected May 03, 2019.
Company Profile
This profile covers OSKO, Inc. based in Medley, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected August 17, 2017. Last inspected May 3, 2019.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate final acceptance procedures2 inspections
- Methods, devices, procedures for testing2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 3, 2019 | OAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1088391 |
| August 17, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1022321 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
OSKO, Inc.
FEI Number
3010666400
Address
8085 Nw 90th St, Medley, Florida 33166, United States
Country
United States
ID: 59db7c12-ecc1-42f9-b116-ae61a9d585a2