1026378
OsteoMed, LLC — FEI 2027754
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 22, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Addison, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |