The FDA has lashed out at India's Wockhardt, saying a plant in the U.S. was using the same questionable drug-testing procedures that led the agency to ban two of Wockhardt's Indian plants last year. The observation is one of a dozen cited in a Form 483 the FDA has issued to Wockhardt's Morton Grove Pharmaceuticals plant, a facility that has been helping prop up Wockhardt in the face of bans on the Indian plants.
Wockhardt acknowledged last week that it received the Form 483 for the plant about 40 miles northwest of Chicago but gave no details about the problems the FDA found. The FDA has now posted the document, showing it ran an inspection that went on for 17 days in January, February and March. The Form 483 criticizes the facility for unsanitary conditions and poor employee sanitation, but much of the report focuses on the "the continued uncontrolled use of 'trial' injections during chromatographic testing to release drug products and monitor stability of drug products after this practice was cited in warning letters issued to two other Wockhardt facilities."
The Indian plants were banned in part because the FDA said Wockhardt was testing "trial samples" of some drugs, then linking results from those to official samples that had not met test requirements. While the company told the FDA that the trial injections at the Morton Grove plant were for "informational use only," the FDA said it is unclear how the company used the data because it was not officially recorded and there was no audit trail. And, like at the Indian plants, Morton Grove allows unfettered access to computers by analysts, meaning that data could be tampered with by virtually anyone there.
Read more: FDA catches Wockhardt U.S. plant using same spurious testing procedures as Indian plants - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-catches-wockhardt-us-plant-using-same-spurious-testing-procedures-india/2014-06-02#ixzz33aXrdjga
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Wockhardt acknowledged last week that it received the Form 483 for the plant about 40 miles northwest of Chicago but gave no details about the problems the FDA found. The FDA has now posted the document, showing it ran an inspection that went on for 17 days in January, February and March. The Form 483 criticizes the facility for unsanitary conditions and poor employee sanitation, but much of the report focuses on the "the continued uncontrolled use of 'trial' injections during chromatographic testing to release drug products and monitor stability of drug products after this practice was cited in warning letters issued to two other Wockhardt facilities."
The Indian plants were banned in part because the FDA said Wockhardt was testing "trial samples" of some drugs, then linking results from those to official samples that had not met test requirements. While the company told the FDA that the trial injections at the Morton Grove plant were for "informational use only," the FDA said it is unclear how the company used the data because it was not officially recorded and there was no audit trail. And, like at the Indian plants, Morton Grove allows unfettered access to computers by analysts, meaning that data could be tampered with by virtually anyone there.
Read more: FDA catches Wockhardt U.S. plant using same spurious testing procedures as Indian plants - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-catches-wockhardt-us-plant-using-same-spurious-testing-procedures-india/2014-06-02#ixzz33aXrdjga
Subscribe at FiercePharma Manufacturing
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