Alkali Metals Limited – FDA EIR, Feb 15, 2019

An FDA Good Manufacturing Practice (GMP) surveillance inspection of Alkali Metals Limited (AML) in Thanam, Andhra Pradesh, India, was conducted from February 11-15, 2019. This was the first FDA inspection for AML, a manufacturer of non-sterile Active Pharmaceutical Ingredients (APIs) intended for human drug products. The inspection followed CPGM 7356.002F and ICH Q7 guidance. The inspection identified significant issues, resulting in an eight-item FDA 483 list of observations. Key violations included the failure to perform timely qualification and validation of manufacturing equipment and the purified water system, as well as overdue requalification of air handling units, which led to API production under un-qualified environmental conditions. The company also failed to implement prospective or concurrent process validations for API production and solvent recovery. Further deficiencies involved inadequate verification of analytical method suitability, insufficient controls over computerized laboratory systems and audit trails, and a lack of ongoing stability testing and annual product reviews. Batch manufacturing records also lacked essential equipment listings and representative labels. AML committed to addressing the observations and submitting a formal response to the Agency within 15 business days.