6 Observations in Hetero Labs ’483
FDA has released the form FDA-483 issued following a 9/19-9/26 inspection at the Hetero Labs Unit 9 active pharmaceutical ingredient (API) manufacturing facility in Narasapuram Village, India. The six observations in the 12-page report were:
- failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
- release of finished APIs and intermediates intended for the U.S. market to an offsite API warehouse without documentation;
- raw materials and quantities documented in batch production records do not support the yields observed for the APIs produced at the firm;
- failure of the quality unit to adequately control documents;
- failure to reconcile the quantities of identification labels issued, used, and returned; and
- failure to document and investigate out-of-specification results obtained by an unregistered facility testing the firm’s APIs and intermediates.