Week of July 22nd 2018 | FDA Sent These Warning Letters to Pharma Companies

A really slow week — 1 letter to a compounding pharmacy and 1 to a firm for misbranded unapproved drug marketing. We cover the compounding pharmacy letter consistent with past practices.


  • Gipsco Investment Corp dba Lee Silsby Compounding Pharmacy (Cleveland Heights, OH) received a warning letter on July 10th 2018 based on the outcome of an inspection ending June 9th 2017 (not a typo). The firm fails to meet the considerations in Section 503A of the FD&C Act. The warning letter identifies 4 GMP deficiencies for sterile product manufacturing. In addition, the products are misbranded because labeling is not compliant with requirements.


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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She 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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