FDA Inspection
OSKO, Inc.OSKO, Inc. – FDA Inspection, Aug 17, 2017
Record Details
This FDA Inspection record concerns OSKO, Inc., with an inspection on August 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · c7457a05-cec3-4cd4-a32a-304b7f115365
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022321
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 1002.30(a)(2)Methods, devices, procedures for testing
- 21 CFR 1020.30(m)(1)Half-value layer--amount of filtration
- 21 CFR 1020.31(c)(1)Independent mA selection
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OSKO, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2019 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for OSKO, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.