713583
J&T Health and Wellness LLC — FEI 1000525872
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5218 | 21 CFR 1040.20(c)(2)(iv) | Timer resetting and causing resumption of radiation emission |