FDA Inspection
OSKO, Inc.OSKO, Inc. – FDA Inspection, May 3, 2019
Record Details
This FDA Inspection record concerns OSKO, Inc., with an inspection on May 3, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c5f936f0-3360-4265-8668-df90f8700b94
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1088391
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
19- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.30(a)(2)Methods, devices, procedures for testing
- 21 CFR 1003.10(a)FDA not notified of defect or noncompliance
- 21 CFR 1020.30(k)Compliance measurements--diagnostic source assembly
- 21 CFR 1020.30(n)Compliance measurement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - documentation
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Other FDA inspections of OSKO, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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