900538
TreyMed, Inc. — FEI 3003007937
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 21, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sussex, WI (United States)
Citations
| ID | CFR | Description |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |