Drugs

Strides Pharma CGMP Violations

A 1/28-2/5 FDA inspection at the Strides Pharma Science drug manufacturing facility in Puducherry, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 7/1 Warning Letter says specific violations were:

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; and
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.

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 Strides manufactures. The agency strongly recommends that the firm retain a qualified consultant to assist it in remediation efforts.

Strides was told to submit (1) an assessment of the extent of data integrity deficiencies at the facility; (2) a current risk assessment of the potential effects of the observed failures on the quality of Stride’s drugs; and (3) a company management strategy that includes details of its global corrective and preventive action plan.

It also was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completion of the steps.

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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