Drugs

Windlas Healthcare Inspection Sees CGMP Issues

An 8/26-8/30/19 FDA inspection at Windlas Healthcare Private Limited, Dehradun, Uttarakhand, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says specific violations were:

failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA 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 firm manufactures. Windlas was told to provide (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and (3) a management strategy for the company that includes the details of a global corrective and preventive action plan. FDA also recommended that Windlas retain a qualified consultant to assist it in meeting CGMP requirements. It says the consultant should also perform a comprehensive audit of Windlas’ entire operation for CGMP compliance and evaluate the completion and efficacy of the company’s corrective and preventive actions before it pursues resolution of its compliance status with FDA.

Windlas was placed on an import alert 1/21. It was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion of all the actions.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome