Laws, Regulations, Guidance, and Concept Papers
The FDA issued a collection of guidance the week of February 18th regarding devices, safety, clinical ICH Quality, and administrative items. WHO and TGA each published two new guidance. It was a busy week on the publication front.
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Enforcement included two warning letters, one to a device firm and one to an OTC drug product manufacturer. Both are located outside the US. A handful of 483s issued to compounding pharmacies. No enforcement actions from Europe published this week. Recalls included those in Classes I through III. FDA posted two import alerts.
Among the product recalls were 64 products recalled by Sage Products. They received a warning letter in July regarding a lack of microbial control for their products as well as identification that their contract manufacturer shared drug manufacturing equipment with car wax and other potentially toxic products.
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About the Author
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