FDA Inspection Preparation, Supply Risk Management, FDA Guidance, and More…
We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter. Device manufacturing violations ranged from failing to evaluate complaints to failing to establish [...]
There were a handful of warning letters issued to drug manufacturers. FDA continues an unrelenting focus on OTC and contract manufacturers.
This week we cover four warning letters: one to a device firm, two to drug manufacturers, and one to a cosmetics company. The two drug warning letters were issued to firms that manufacture OTC products, continuing FDA’s focus on this market segment.
This week, enforcement was busy with a GLP warning letter, warning letters to an API manufacturer, a pharmaceutical firm, a couple of compounding pharmacies, and a device firm.
We cover four recent warning letters, including one to a drug manufacturer, one to a distributor, and two to medical device firms.
This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert.
The global supply chain for drug products sold in the US has become increasingly more complicated in the past decades.