FDA EIR - Stratus Pharmaceuticals Inc - December 08, 2014

An FDA for-cause cGMP inspection of Stratus Pharmaceuticals Inc., an own-label distributor of prescription and OTC drugs in Miami, FL, was conducted from November 18 to December 8, 2014. This inspection was initiated as a follow-up to significant cGMP deficiencies found at their co-owned contract manufacturer, Sonar Products Inc. The inspection identified several critical violations, documented on an FDA-483. Stratus Pharmaceuticals demonstrated inadequate written procedures for complaint handling, notably failing to forward 1,362 product quality complaints (including over 1,000 for defective Hypercare 20% Solution applicators) to its contract manufacturer for investigation and trending. The firm also lacked a defined quality control unit with documented responsibilities for critical quality activities like label approval and product release. Procedures for reporting serious adverse drug experiences and documentation of employee cGMP training were also deficient. Furthermore, a major verbal observation highlighted the unapproved status of all Stratus's prescription drug products, which were being marketed without required FDA drug applications. Labeling deficiencies were also noted for certain multi-vitamin products. Management, represented by President Alberto Hoyo, promised corrective actions, a written response within 15 business days, and outlined plans to engage external firms to achieve cGMP compliance, conduct clinical trials, and submit drug applications for their prescription portfolio.