1013314
Burke, Inc. — FEI 1919278
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 8, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kansas City, KS (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |