FDA EIR - Unknown Company - July 27, 2018

A routine surveillance inspection of Solara Active Pharma Sciences Limited, a manufacturer of active pharmaceutical ingredients for human and animal drug products, was conducted by the Food and Drug Administration (FDA) from July 23 to July 27, 2018. This inspection was guided by Compliance Program Guidance Manual 7356.002 F for Active Pharmaceutical Ingredient (API) Process Inspection, focusing on quality, facilities, equipment, materials, production, and laboratory systems. The inspection resulted in a 2-item FDA Form 483, indicating significant observations. The primary violations included inadequate written procedures for equipment cleaning and release, lacking sufficient detail for reproducible and effective cleaning of intermediates or APIs. Additionally, method validation for forced degradation of active pharmaceutical ingredients did not ensure the test method's adequacy for its intended use. Further discussion points not on the Form 483 involved missing batch numbers in microbial load study reports for cleaned equipment and insufficient investigation into returned items with labeling errors, particularly regarding transportation storage conditions, before redistribution. The company committed to providing a written response to the FDA 483 observations within 15 business days. The inspection was classified as Voluntary Action Indicated (VAI).