Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

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Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

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.

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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.

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About the Author

Barbara W. Unger

Barbara W. Unger formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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