Key Points
The U.S. drug regulator flagged 10 procedural lapses at Lupin Ltd.s manufacturing facility in Pithampur, Madhya Pradesh, of which four were repeat observations..
The plant manufactures oral and ophthalmic products...
Investigations into the failure of a batch or any of its components to meet any specifications did not extend to other drug products that may have been associated with the discrepancy..
Employees engaged in the manufacturing, processing, packing, and holding of drug products lack the training required to perform their assigned functions..
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures to assure the quality and purity of components and drug products...
