FDA 483 - Preferred Pharmaceuticals, Inc. - January 14, 2020

Preferred Pharmaceuticals, Inc., a drug repackager/relabeler in Anaheim, CA, received a Form 483 for two significant observations. The firm was cited for not having established written procedures for in-process controls and tests during its repackaging process, leading to inadequate verification of dispensed pill quantities. Additionally, the qualification of its pill counting equipment was deemed insufficient, with current verification methods failing to adequately challenge the machines for potential miscounts.