Monday, October 31, 2016

Recordkeeping Issues Cited in Form 483 for Belcher Pharmaceuticals

Recordkeeping and reporting issues were cited multiple times in a Form 483 received by Belcher Pharmaceuticals. Read More
FDA’s New Inspection Protocol Begins to Have Impact
October 30, 2016
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
Two Companies Get Warning Letters Over Misbranded Drugs, Product Specification
October 28, 2016Ajes Pharmaceuticals and Positive Power Nutrition have been hit with warning letters after the FDA conducted inspections. Read More

No comments: