FDA Inspection 966462 — S & T AG
The FDA completed an inspection of S & T AG on Mar 23, 2016 in Neuhausen. 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
- Mar 23, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Neuhausen (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |