Fusion IV Pharma Compound Facility Hit With FDA Warning Letter

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward medical research investigators and institutions.

Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceutical

• Issuing Office: FDA’s Division of Pharmaceutical Quality Operations
• Recipient: Navid Vahedi (Owner), Los Angeles
• Date: Feb. 21, 2018 (posted May 1, 2018)
• Inspection of Los Angeles facility from March 13, 2017, to March 23, 2017.

Alleged Infractions

• Failure to include proper labels on drug containers, including “Office Use Only” and information to report adverse drug effects.
• Failure to report to FDA when initially registering as an outsourcing facility and failure to report which drugs ...