FDA Inspection 1243315 — SEKO MedTec Solutions
The FDA completed an inspection of SEKO MedTec Solutions on Jul 8, 2024 in Oakdale, PA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 8, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oakdale, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3308 | 21 CFR 820.120(a) | Remain legible |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |