FDA Inspection 920421 — Elite Massagers, LLC.
The FDA completed an inspection of Elite Massagers, LLC. on April 14, 2015 in Allen, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 14, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Allen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |