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FDA Releases 32-page Hospira India FDA-483

FDA has released a 32-page FDA-483 issued following a 3/27-4/3 inspection at Hospira Healthcare India, Tamil Nadu, India. The 11 observations in the report were: 

  •          failing to follow responsibilities and procedures applicable to the quality control unit;
  •          failing to have laboratory records include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards;
  •          failing to have testing and release of drug product for distribution include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release;
  •          failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
  •          failing to include conclusions and follow-up in written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications;
  •          failing to establish control procedures 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;
  •          failing to establish, write, and follow procedures to prevent microbiological contamination of drug products purporting to be sterile;
  •          failing to follow and document at the time of performance written production and process control procedures in evaluating production and process control functions;
  •          failing to establish and document the accuracy, sensitivity, and reproducibility of test methods;
  •          failing to calibrate instruments at suitable intervals in accordance with an established written program and with provisions for remedial action in the event accuracy and/or precision limits are not met; and
  •          failing to submit a field alert report within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

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