3 Observations from Lupin Inspection

FDA has released the FDA-483 issued following a 5/6-5/15 inspection at Lupin, Ltd., Aurangabad, Maharashtra, India. The form’s inspection observations for the manufacturer of finished drugs were: 

1.          written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up;
2.          laboratory controls do not include establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
3.          control procedures are not established that monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.