Wockhardt gets USFDA warning for violation of norms at UK facility
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Mumbai: Wockhardt Ltd has received a warning letter from the US Food and Drug Administration (USFDA) for violation of good manufacturing practices (cGMP) at the facility of its indirect subsidiary, CP Pharmaceuticals, at Wrexham in the UK, according to information on the USFDA’s website.
“Currently, there is no business being conducted from CP Pharmaceuticals to the US market. CP Pharmaceuticals has already initiated required steps to address the concerns raised by the US FDA and will be responding to the agency within the prescribed time,” Wockhardt said in a stock exchange filing.
Three plants of Wockhardt in India are already under an import ban in the US. The company’s formulations units at Chikalthana and Waluj in Maharashtra have been under the USFDA’s import alert since 2013, while its bulk drug plant at Ankleshwar in Gujarat was issued an import alert in August.
The US regulator also observed violation of cGMP at the company’s formulations plant in Shendra, Maharashtra, earlier this year.
The US drug regulator inspected CP Pharmaceuticals’ manufacturing facility in the UK between 5 and 13 October, 2015, and made certain observations relating to deviations from cGMP.
The issuance of the warning letter is because the USFDA was not satisfied with corrective measures taken at the UK plant.
CP Pharmaceuticals is step-down subsidiary of Wockhardt with a turnover of Rs.553.52 crore in the year ended 31 March 2016.
The warning letter highlights that the firm failed to follow appropriate written procedures designed to prevent microbiological contamination of drugs claiming to be sterile and the inspectors observed poor practices during aseptic set-up and filing processes, including inadequate monitoring of personnel in the aseptic production observations and inadequate disinfection process.
“Based upon the nature of the violations we identified at your firm and because you failed to correct repeat violations, we strongly recommend engaging a qualified consultant to assist your firm in meeting cGMP requirements for aseptic processing,” the USFDA said in the warning letter.
Until the company corrects all violations and the USFDA confirms its compliance with cGMP, the regulator may withhold approval of any new applications or supplements filed from the UK facility.
The company has to respond to the US drug regulator in writing within 15 working days of receiving the warning letter, giving details of what it has done since the October 2015 inspection to correct the violations and prevent their recurrence.
In the response letter, the USFDA has asked Wockhardt to provide a comprehensive evaluation of design, control, maintenance and oversight of aseptic processing lines, a risk assessment of potential effects of the deficiencies observed in the drugs, and an overall strategy on how the management will oversee improvements in operations and ensure sustainable quality assurance.
Shares of Wockhardt fell nearly 5% on Wednesday to a 52-week low of Rs.657 on the National Stock Exchange.