Drugs

CGMP Problems Found in Wockhardt Inspection

A 12/7-12/15/15 FDA inspection at Wockhardt Limited, Mumbai, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients, according to a 12/23/16 Warning Letter. The letter says that violations and deviations included:

failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failing to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination;
failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards;
failing to exercise appropriate controls over computer or related system to assure that only authorized personnel institute changes in master production and control records, or other records; and
failing to record activities at the time they are performed, and destruction of original records.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says. “We strongly recommend that you retain a qualified consultant to assist in your remediation.” The company was told to submit a comprehensive investigation into the inaccuracies in data records and reporting, a current risk assessment of the potential effects of the observed failures on the quality of its drugs, and a management strategy with the details of a global corrective action and preventive action plan.

FDA placed the company on an Import Alert 8/5/16. Wockhardt was told to respond with a list of steps taken since the inspection to correct the violations and deviations and prevent their recurrence, with a timetable for completion.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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