FDA EIR - BioZone Laboratories, Inc. - January 26, 2016

An FDA inspection of Biozone Laboratories Inc., a contract drug manufacturer, was conducted from January 13-26, 2016. This routine surveillance inspection, under the Human Drug CGMP Site Surveillance program and relevant Compliance Program Guidance Manuals, aimed to assess compliance with Good Manufacturing Practices for topical prescription and Over-the-Counter (OTC) drug products. The inspection identified several significant issues, leading to the issuance of a four-item FDA Form 483.Key violations included the quality control unit failing to review and approve laboratory control mechanisms, and inadequate storage conditions for drug products, which could compromise their quality. Additionally, the firm lacked or failed to follow written procedures for instrument calibration and annual batch record evaluations. Beyond the formal observations, verbal discussions highlighted concerns regarding the marketing of unapproved new prescription drugs, such as certain Selenium Sulfide and Sodium Sulfacetamide & Sulfur products, which lacked FDA-approved applications. The firm also appeared to be marketing an OTC pain cream with an active ingredient concentration outside its monograph's typical analgesic classification and a medical device beyond its cleared indications for use. Furthermore, the absence of written quality agreements with some customers for prescription and OTC products was noted. Biozone Laboratories Inc. is required to provide a written response addressing these observations and concerns to the FDA within 15 business days.