FDA Inspection 1147977 — Liposales LLC

Liposales LLC — FEI 3015049754

The FDA completed an inspection of Liposales LLC on Aug 5, 2021 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Aug 5, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Houston, TX (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313221 CFR 820.120Lack of or inadequate procedures for labeling
313921 CFR 820.140Lack of or inadequate procedures for handling
367421 CFR 820.30(d)Design output - documentation

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.