The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. This is a slow enforcement week for drugs and devices.
COMPOUNDING PHARMACY:
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical (Los Angeles, CA) received a warning letter on February 21st 2018 based on the outcome of an inspection ending March 23rd 2017. The products failed to meet the requirements of section 503b of the FDCA; there were identified failures in aseptic practices and stability determinations. FDA also provided a listing of the firm’s corrective actions that were deemed deficient.