This was a very light week for warning letters all around with a total of two new ones posted by FDA. One was issued to a device manufacturer and we cover it below. The other was issued regarding an unapproved new drug that was also misbranded. Looks to be a dietary supplement containing API from approved drug products. The device letter is covered below.
DEVICE | Abraxis Inc
Abraxis Inc (Union City, CA) received a warning letter on April 12, 2019 based on the outcome of an inspection ending April 25, 2018. The firm manufactures and distributes Class I and II in vitro diagnostic reagents including a chemistry analyzer and associated assays. The firm made changes that impacted the potassium assay calibrations and resulted in customer complaints. The firm did not assess whether the modifications made could impact the safety or efficacy of the product. The single deficiency identified that the firm failed to establish and implement design change procedures.
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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.
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