FDA said unit of plant quality does not have documented procedures and some systems were not followed
Irregularities in testing similar products were also cited two warning letters issued to prohibited plants and Wockhardt in Chikalthana Waluj in Aurangabad, India. Photo: Kedar Bhat / Mint
Wockhardt Ltd, the manufacturer of generic drugs has faced quality problems at two of its plants in India, was quoted by the Food and Drug Administration (FDA) for testing lapses at a factory in Illinois.
FDA issued a Form 483 listing possible violations of the Act Food Drug and Cosmetic Act after inspecting facilities for drug Wochardt in Morton Grove, Illinois, more than 17 days between January and March, according to a document on the website of the agency.
Two of the facilities of the Indian drug maker based in Mumbai and are prohibited from exporting to the U.S. after FDA inspections reported similar violations. If Wockhardt ignores problems, recent observations could affect the company's offerings to its biggest market.
The facility generates more than half of Wockhardt's U.S. sales last quarter. U.S. Business Wockhardt fell 26% in the year ended March 2014 following the import restriction on the other two factories. The contribution of U.S. sales dropped to 45% of total revenue 51% last year.
Form 483, issued on March 26 and contains 12 observations, that unit of plant quality does not have documented procedures and some systems were not followed.
The Wockhardt factory in Illinois is the latest installment in India under scrutiny by the FDA. Four factories of India Ranbaxy Laboratories Ltd are prohibited from selling to the U.S. and this year the FDA put import restrictions on a plant Sun Pharmaceutical Industries Ltd.
Drug Testing
The document cited the specific practice of testing test and said the company has not established appropriate procedures designed to ensure that products conform to appropriate standards of identity, strength, quality and purity.
Irregularities in testing similar products were also cited two warning letters issued to prohibited facilities Wockhardt in Chikalthana and Waluj in Aurangabad, India, the document says, leading the agency to believe that the unity of quality business is not fully monitoring systems in their plants.
The FDA also cited evidence RAW data files that could be accessed and removed by anyone, and workers not trained in good manufacturing practices today.
"It's hard to say what kind of position will make the FDA," said managing director Murtaza Khorakiwala on 27 May call with analysts, referring to the last inspection. "But I think that, in our opinion, the inspection was not-I mean, it was not a negative inspection." Dominic D'Souza, a spokesman for Wockhardt in Mumbai, declined to comment Tuesday on the FDA document.
Irregularities in testing similar products were also cited two warning letters issued to prohibited plants and Wockhardt in Chikalthana Waluj in Aurangabad, India. Photo: Kedar Bhat / Mint
Wockhardt Ltd, the manufacturer of generic drugs has faced quality problems at two of its plants in India, was quoted by the Food and Drug Administration (FDA) for testing lapses at a factory in Illinois.
FDA issued a Form 483 listing possible violations of the Act Food Drug and Cosmetic Act after inspecting facilities for drug Wochardt in Morton Grove, Illinois, more than 17 days between January and March, according to a document on the website of the agency.
Two of the facilities of the Indian drug maker based in Mumbai and are prohibited from exporting to the U.S. after FDA inspections reported similar violations. If Wockhardt ignores problems, recent observations could affect the company's offerings to its biggest market.
The facility generates more than half of Wockhardt's U.S. sales last quarter. U.S. Business Wockhardt fell 26% in the year ended March 2014 following the import restriction on the other two factories. The contribution of U.S. sales dropped to 45% of total revenue 51% last year.
Form 483, issued on March 26 and contains 12 observations, that unit of plant quality does not have documented procedures and some systems were not followed.
The Wockhardt factory in Illinois is the latest installment in India under scrutiny by the FDA. Four factories of India Ranbaxy Laboratories Ltd are prohibited from selling to the U.S. and this year the FDA put import restrictions on a plant Sun Pharmaceutical Industries Ltd.
Drug Testing
The document cited the specific practice of testing test and said the company has not established appropriate procedures designed to ensure that products conform to appropriate standards of identity, strength, quality and purity.
Irregularities in testing similar products were also cited two warning letters issued to prohibited facilities Wockhardt in Chikalthana and Waluj in Aurangabad, India, the document says, leading the agency to believe that the unity of quality business is not fully monitoring systems in their plants.
The FDA also cited evidence RAW data files that could be accessed and removed by anyone, and workers not trained in good manufacturing practices today.
"It's hard to say what kind of position will make the FDA," said managing director Murtaza Khorakiwala on 27 May call with analysts, referring to the last inspection. "But I think that, in our opinion, the inspection was not-I mean, it was not a negative inspection." Dominic D'Souza, a spokesman for Wockhardt in Mumbai, declined to comment Tuesday on the FDA document.
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