US drug regulator issues warning to Wockhardt’s Ankleshwar plant

The US Food and Drug Administration (FDA) has issued a warning to Wockhardt’s Ankleshwar plant on data integrity, record destruction and other alleged violations of good manufacturing practices.

In its warning letter, the FDA has said the company has failed to prevent microbiological contamination, record the data on medical tests and ensure that only the authorised personnel made changes in production and controlled records.

“Your (Wockhardt) 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 FDA said in its December letter, recommending the appointment of a consultant for remediation measures.

The company's three plants, including the one in Ankleshwar, are under an import alert. The move is a setback to the company’s plans to revive its US business. The share of the firm’s US sales dropped to 22 per cent of the total in FY16 from 24 per cent in the previous year because of import restrictions. The Ankleshwar plant contributes 10-15 per cent of the US sales (~964 crore in FY16). The FDA had done an inspection at the Ankleshwar plant in December 2015 and made adverse remarks, known as Form 483, on allegedly violating good manufacturing practices. The Ankleshwar plant makes formulations and active pharmaceutical ingredients (APIs) and largely caters to the domestic and European markets. However, it exports some formulations and APIs to Wockhardt’s US plant.

Wockhardt's plants in Chikhalthana and Waluj in Aurangabad have received import alerts. At present, the firm is able to export only two products from Chikhalthana to the US. Other than this, Wockhardt serves the US market from its manufacturing plant in Chicago.