932518
Troy Innovative Instruments Inc — FEI 3000718985
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 30, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Middlefield, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 537 | 21 CFR 820.70(a) | Production processes |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |