Aurobindo Pharma FDA-483 Released

FDA has released the FDA-483 issued following a 4/10-4/18 agency inspection at Aurobindo Pharma, Hyderabad, Telangana, India. Inspection observations included: 

•         failing to have laboratory controls include establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality, and purity;
•          failing to give the quality control unit authority to fully investigate errors that have occurred;
•          failing to maintain in writing and to fully follow the responsibilities and procedures applicable to the quality control unit;
•          failing to record and justify deviations from written test procedures;
•          failing to validate sensitivity of test methods; and
•          failing to include in laboratory records complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards.