USFDA asks Wockhardt to assess quality systems across its plants

The USFDA has asked drug maker Wockhardt to assess the company’s global manufacturing operations in light of repeated violations at multiple sites. These sites were reportedly found not to have complied with the agency’s current good manufacturing practices (CGMP).Taking note of CGMP violations across seven Wockhardt facilities including Morton Grove, the USFDA said repeated failures at multiple sites “demonstrate your company’s inadequate oversight and control over the manufacture of drugs.”“In your responses to the various actions listed above, including during multiple meetings with (US)FDA, you have repeatedly discussed and promised corporate-wide corrective actions. Yet, when (US) FDA inspects or returns to other Wockhardt facilities, similar violations are shown to persist,” USFDA observed in the warning letter dated February 17, issued to company’s Morton Grove facility in Illinois, US.The contents of the warning letter were made public by USFDA on Tuesday. Morton Grove facility was inspected by USFDA from January 4 to February 5, 2016.US drug regulator called for Wockhardt’s executive management to take full responsibility for resolving all deficiencies and ensure ongoing CGMP compliance.The agency also sought an overhaul of quality systems and processes across company global manufacturing operations.“You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to (US) FDA requirements,” USFDA said.USFDA highlighted six CGMP violations at Morton Grove facility that mainly dealt with failure to investigate batch failures, glitches in recording keeping, lapses in quality control procedures and unauthorised access.USFDA also pinpointed data integrity issues and asked the company to come up with three key expectations - comprehensive investigation into the extent of the inaccuracies in data records and reporting; risk assessment of the potential effects of the observed failures on the quality of drugs; and management strategy that includes the details of your global corrective action and preventive action plan. Wockhardt has 12 plants, of which nine are located in India, with one each in the US, UK and Ireland.Analysts felt that while the latest warning letter may not impact its earnings estimates, it is certainly a setback to the company's ongoing remediation programmes.For its part, Wockhardt has been proactively trying to weather the storm. It has enlisted external consultants to aid its extensive remediation exercise. Read more at: http://www.moneycontrol.com/news/business/wockhardt-awaits-cure-for-its-never-ending-regulatory-pain_8587301.html?utm_source=ref_articleAn external consultant Moneycontrol spoke to said on condition of anonymity that issues raised by USFDA in the warning letter are 'damning’ and indicates that resolution of Wockhardt regulatory problems could be a long-drawn one.Share of Wockhardt rose 0.24 percent to close at Rs 739.15 on BSE on Wednesday, while the benchmark declined 0.34 percent to 28,901.94 points.Wockhardt plants under USFDA scannerWaluj plant, Maharashtra - Import alert, May 2013Chikalthana plant, Maharashtra - Import alert, November, 2013Ankleshwar API plant, Gujarat – Import alert, August, 2016CP Pharma, UK - Warning letter, November 2016Shendra plant, Maharashtra - Form 483 Observations, January, 2016Morton Grove, US - Warning letter, March, 2017