FDA Inspection 1022321 — OSKO, Inc.
The FDA completed an inspection of OSKO, Inc. on Aug 17, 2017 in Medley, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 17, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Medley, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 5475 | 21 CFR 1020.30(m)(1) | Half-value layer--amount of filtration |
| 5504 | 21 CFR 1020.31(c)(1) | Independent mA selection |
| 5813 | 21 CFR 1002.30(a)(2) | Methods, devices, procedures for testing |