Drugs

CGMP Problems Found at India’s Vital Laboratories Private

David McFarland

— 1 min read
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A 4/3-4/6 FDA inspection at Vital Laboratories Private Limited, Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients, according to a 10/10 Warning Letter. Specific deviations cited in the letter were: 

  •          failing to ensure all production deviations are reported and evaluated, and that critical deviations are investigated, and the conclusions recorded;
  •          failing to adequately document the completion of each significant step in the batch production records with signatures of the persons performing and directly supervising or checking each critical step in the operation;
  •          failing to adequately investigate and document out-of-specification results and implement appropriate corrective actions; and
  •          failing to have the quality unit adequately perform annual product reviews. 

The letter says the company’s responses to the four observations were inadequate. It also notes that similar CGMP deviations were found when other facilities in the firm’s network were inspected. “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” it says.

FDA says it strongly recommends that the company engage a consultant who is qualified to evaluate its operations and assist it in meeting CGMP requirements. The firm was told to respond with list of steps it has taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.

 

 

 

 

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