FDA Inspection 889077 — Compass Richmar LLC
The FDA completed an inspection of Compass Richmar LLC on July 30, 2014 in Chattanooga, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 30, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Chattanooga, TN (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 |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 5007 | 21 CFR 1002.13 | Failure to submit |