FDA 483 - Teena Bio Labs Private Ltd - March 15, 2017

Teena Biolabs Pvt. Ltd. in Quthbullapur, India, a control testing laboratory, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in laboratory records, specifically the failure to retain original electronic data for residual solvent analysis. Additionally, the firm did not verify the suitability of its testing methods or perform system suitability testing for its gas chromatograph, raising concerns about the accuracy and reliability of analytical results.