End of Wockhardt’s Chikalthana USFDA woes?

By: |
April 05, 2015 8:20 AM

No major findings from recent USFDA inspection, after 2013 import alert on the company's Aurangabad-based Waluj and Chikalthana facilities

No major findings from recent USFDA inspection, after 2013 import alert on the company’s Aurangabad-based Waluj and Chikalthana facilities

Wockhardt Pharma’s Chikalthana facility in Maharashtra recently underwent a 10-day-long inspection by the USFDA. Chairman, Dr Habil Khorakiwala informed media representatives at the company’s global headquarters in Mumbai that there were no major irregularities found during the inspection. It is to be noted that in 2013, the USFDA had issued an import alert on the company’s Aurangabad-based Waluj and Chikalthana facilities.

In a statement to National Stock Exchange of India (NSE), the company said, “The audit focus was to assess our GMP remediation and our efforts made to bring about culture change and to build a robust quality management. The efforts for data security control have been thoroughly verified during the inspection and have been appreciated as it is qualified and executed since September 2013. There were no findings with respect to data security and control measures in laboratory and manufacturing. The observations on Form FDA 483 are on products manufactured prior to execution and implementation of GMP remediation programme.”

Khorakiwala said, “Chikalthana plant inspection is a forward movement for us. We clearly know regulators’ additional requirements and we will try to comply with them. As suggested by the concerned authorities, we have reviewed all the products manufactured from 2013, batch-wise. In the last one month, USFDA authorities have visited Waluj and Chikalthana plants and the company believes that remaining facilities will also be inspected by them in short period of time.”

According to him, the company has employed various remedial measures across all the facilities in order to ensure the GMP compliance. The senior level manufacturing and quality team is completely new. Extensive GMP-related training has been conducted for the staff. The company has built a complete IT infrastructure and now data cannot be tampered with. All the locations have been electronically connected. The company has also created an office of global quality which consists of leadership from India, the UK and the US.

EP News BureauMumbai

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