FDA 483 - Sai Life Sciences Limited

An FDA inspection of Sai Life Sciences Ltd., Unit II, a testing laboratory in Hyderabad, Telangana, revealed significant deficiencies in their LIMS implementation and qualification. The firm failed to assure that API and in-process materials conformed to specifications due to inadequate verification of instrument functionality and unverified calculations within the LIMS system. This raises concerns about data integrity and product quality for products released to the US market.