Life Sciences

Sandoz receives FDA warning letter

Pharma Compliance Alert, September 3, 2008

An FDA inspection revealed significant deviations from Good Manufacturing Practice at Novartis’ Sandoz generic unit’s manufacturing facility, according to an agency warning letter.

The FDA found Sandoz failed to:
  • Establish and follow written procedures for production and process controls
  • Thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications
  • Include in-process and laboratory control results in the batch record
  • Include complete manufacturing and control instructions, sampling and testing procedures, specifications, and precautions to be followed
  • Have laboratory controls to establish scientifically sound and appropriate specifications, standards, sampling plans, and test procedures
  • Establish appropriate controls over computer or related systems
  • Ensure that the responsibilities and procedures applicable to the quality control unit are followed

Most of the problems the FDA reported in the warning letter relate to Metoprolol, but the agency expressed concern that the violations could be indicative of problems and poor decisions made with other product validations.

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