FDA EIR - Lantech Pharmaceuticals Ltd. - March 15, 2019

An FDA "For Cause" inspection of Lantech Pharmaceuticals Limited in Andhra Pradesh, India, was conducted from March 6 to March 15, 2019. The inspection focused on the company's solvent recovery operations due to its implication as a potential source of N-nitrosamine (NDMA and NDEA) contamination in Active Pharmaceutical Ingredients (APIs) such as Valsartan, Telmisartan, and Lamivudine. The inspection adhered to Compliance Program 7356.002F and ICH Q7 guidelines. The inspection revealed nine significant observations, indicating a failure to fully correct issues from a previous April 2018 inspection. Primary violations included inadequate investigations into nitrosamine contamination, specifically failing to evaluate all potential root causes, consider NDMA, or assess cross-contamination risks across different APIs and shared equipment. Other critical issues identified were inadequate equipment cleaning, insufficient control over electronic Quality Control laboratory data, lack of Quality Unit oversight, and absence of process validation for solvent recovery. Furthermore, corrective and preventive actions were not consistently documented, production equipment storage was inappropriate, and solvent status was not properly identified. Management, led by Mr. V. Prakash Reddy, acknowledged these deficiencies and committed to corrections, promising a written response to the Agency within 15 United States business days.