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Import alert issued to Wockhardt by USFDA

The US Food and Drugs Administration (FDA) issued an import alert on Wockhardt’s Ankleshwar plant on account of GMP violations. The US FDA had carried out an inspection at the Ankleshwar plant in November last year and issued adverse observations known as Form 483 for violating good manufacturing practices.

Ankleshwar is the third plant to receive import alert from USFDA. Other than Ankleshwar, Wockhardt's plants in Chikhalthana and Waluj in Aurangabad have import alerts against them. Highlights from that warning letter for Waluj included the facility’s manufacture of a product intended for US export, but the company did not tell FDA about its existence until investigators identified it. FDA found at the Waluj site "approximately 75" unofficial batch records "torn in half in a waste area" confirming that many batches did not meet established visual inspection criteria. Those batches reportedly included "black particles, fibers, glass particles, sealing defects and volume variations."

In January, the US FDA had issued adverse observations to the company's Shendra plant.



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