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Transdermal Patches Repackaged In Zippered Plastic Bags? FDA Sees Problems

Executive Summary

The owner of Phase 4 Pharmaceutical says FDA's recent warning letter isn't the agency's first 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 deficiencies by noting Phase 4 repackages OTC transdermal patches in zippered plastic bags.

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