FDA Inspection 1147977 — Liposales LLC
The FDA completed an inspection of Liposales LLC on August 5, 2021 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |