FDA Inspection 1085890 — D R Burton Healthcare LLC
The FDA completed an inspection of D R Burton Healthcare LLC on April 11, 2019 in Farmville, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 11, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Farmville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |