Transdermal Patches Repackaged In Zippered Plastic Bags? FDA Sees Problems

摘要

The owner of Phase 4 Pharmaceutical says FDA's recent warning letter isn't the agency's aerst contact with him about his manufacturing and marketing practices. The letter, the only one addressed to Phase 4 in FDA's warning letters database, begins its list of GMP deaeciencies by noting Phase 4 repackages OTC transdermal patches in zippered plastic bags.