948861
Sunshine USA, LLC — FEI 3009973354
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 19, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Johnson City, TN (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5046 | 21 CFR 1010.3(a)(2)(ii) | Manufacture date abbreviated or unapproved date coding |