USFDA warning to Wockhardt's Ankleshwar plant over data integrity issues

Three of firm's units under import alert; FDA cites failure to check microbiological contamination

US Food and Drug Administration (USFDA) has issued a warning letter to Wockhardt's Ankleshwar plant for data integrity issues, destruction of records and other violation of good manufacturing practices.

Three of the company's plants, including the one at Ankleshwar, are under an import alert.

In its warning letter FDA said the company failed to take measures to prevent microbiological contamination. Further it said the company failed to record complete data of medical tests and failed to exercise control over computers to ensure only authorised personnel make changes in production and control 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," FDA said in its last month letter recommending appointment of a consultant for remediation measures.

The move is a setback to the company's plans to revive its US business. The share of the firm's US business in the total sales dropped to 22 per cent in FY16 from 24 per cent a year ago because of import restrictions. The Ankleshwar plant contributes 10-15 percent of the US sales (Rs 964 crore in FY16).

The USFDA had carried out an inspection at the Ankleshwar plant in December 2015 and issued adverse observations known as Form 483 for violating good manufacturing practices.

The Ankleshwar plant is used to make both formulations and active pharmaceutical ingredients and largely caters to domestic and European markets. However, it exports some formulations and active pharmaceutical ingredients (APIs) to Wockhardt's US plant.

Wockhardt's plants in Chikhalthana and Waluj in Aurangabad have import alerts against them. At present, the company 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.