FDA 483 - Nosch Labs Private Ltd - September 13, 2024

An FDA inspection of Nosch Labs Private Limited, an Active Pharmaceutical Ingredient manufacturer in Veliminedu, India, was conducted from September 9-13, 2024. The inspection resulted in an FDA 483 document, highlighting multiple deviations from regulatory expectations for quality control and manufacturing practices. Significant issues included inadequate controls on testing equipment, specifically the Karl Fischer moisture analyzer and HPLC systems, and a lack of proper method suitability evaluations for product release testing. The firm was also cited for using unqualified, non-traceable laboratory-grade reagents and chemicals as reference standards for critical analyses such as water content, assay, and residual solvents. Additionally, analytical test methods, including those for cleaning validation, were not appropriately validated, demonstrating deficiencies in linearity and recovery studies. The inspection also found that process validation for glassware sterilization was unreproducible, with issues in biological indicator recovery and traceability. Furthermore, the company failed to adequately evaluate rejected product batches for particulates or determine their probable source. Finally, water sampling plans for microbiological analysis were not scientifically sound or representative of actual manufacturing use, with no specific microbial speciation performed. These observations collectively indicate a need for Nosch Labs to implement robust corrective and preventive actions to ensure compliance with current Good Manufacturing Practices and uphold product quality.