1080894
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. — FEI 3002698769
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 15, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Whitestown, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |