Just Issued Recalls, 483s, Laws, & Warning Letters | September 2018

/, CGMP, FDA Enforcement News, FDA Warning Letters, Form FDA 483, Medical Devices/Just Issued Recalls, 483s, Laws, & Warning Letters | September 2018

Just Issued Recalls, 483s, Laws, & Warning Letters | September 2018

Enforcement:

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Laws & Guidance:

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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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