FDA 483 - UMED PHARMA LAB PRIVATE LIMITED

An FDA inspection of UMED Pharma Lab Private Limited, a contract testing laboratory in Telangana State, India, revealed significant deficiencies in computer system controls and laboratory procedures. Observations included inadequate management of analytical instrument methods and microbiology equipment audit trails, leading to data integrity concerns and unaddressed alarm conditions. Additionally, the firm lacked scientifically sound test procedures, allowing critical equipment like incubators to operate out of range without proper justification or established corrective action protocols.