FDA Inspection 1013314 — Burke, Inc.
The FDA completed an inspection of Burke, Inc. on June 8, 2017 in Kansas City, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: 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 |