FDA Warns Intas About Multiple Violations

A 7/28 Warning Letter cites Sanand, India-based Intas Pharmaceuticals for current good manufacturing practice (CGMP) violations found during an 11/22/22-12/2/22 FDA inspection. The letter says specific violations were: 

• failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity;
• failing to ensure that laboratory records include complete data derived from all tests necessary to ensure compliance with established specifications and standards;
• failing to establish and follow required laboratory control mechanisms;
• failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
• failing to establish the accuracy, sensitivity, specificity, and reproducibility of test methods.

FDA says Intas’ responses to four of the inspection observations were inadequate. The letter acknowledges the company’s plans to conduct new smoke studies under dynamic conditions to improve its evaluation of the effect of interventions and interactions on airflow within the restricted access barrier system.

Intas’ quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures, FDA says. The agency acknowledges the company is using a consultant to audit its operation and assist in meeting CGMP requirements.

FDA notes that similar CGMP violations were cited in a 2019 inspection and that Intas had proposed specific remediation for those observations in its response at that time. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it says.

The letter further finds the company has an ineffective quality system, test results that are out-of-specification, and process validation issues. The agency placed Intas on a 6/1 Import Alert.

The company was told to correct violations promptly and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.