Drugs

Multiple Violations at Pritam International

David McFarland

— 1 min read
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A 6/2-6/6 FDA inspection at the Pritam International Private Limited drug manufacturing facility in Uttarakhand, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/27 Warning Letter says the agency also determined that the firm contract manufactures an over-the-counter toothpaste and redacted drug products and that the toothpaste contains a color additive for which FDA has cancelled its certification.

The letter lists these CGMP violations:

  • failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
  • failure to conduct at least one test to verify the identity of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and
  • failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA recommends that Pritam engage a qualified consultant to perform a comprehensive six-system evaluation of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of the firm’s corrective and preventive actions before Pritam pursues resolution of its compliance status with the agency.

The letter also says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the company manufactures. It recommends that Pritam retain an independent, qualified third-party consultant to assist in data integrity remediation.

FDA acknowledges that on 9/10, the company recalled all toothpaste drug products within expiry currently in distribution in the U.S. FDA placed all of Pritam’s drugs and drug products offered for import into the U.S. on a 9/3 Import Alert.

The company was told to promptly address the noted violations and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.

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