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Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Oct 24th, 2010

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Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe.

In mid-October, the agency posted letters it had recently issued to two active pharmaceutical ingredient (API) firms in China and Japan, respectively, to a contract testing laboratory in India and to a contract tablet and powder manufacturer in Belgium – all of which reference deficiencies in lab practice.

The four warning letters also showcase the growing emphasis FDA investigators are placing on the quality assurance linkages between the participants involved in the supply chain.

The API manufacturers receiving the letters were Hofu City, Japan-based Kyowa Hakko Kogyo and Shulan City, China-based Jilin Shulan Synthetic Pharmaceutical.   The letter went out to Kyowa in late September referencing a June inspection, and to Jilin in May addressing findings during a late-August 2009 inspection.

Warning letters went out to Hyryana, India-based Choksi Laboratories and Qualiphar in Bornem, Belgium at the end of September – both referencing findings from inspections in the late April-early May timeframe.

In line with FDA procedures, the four foreign warning letters were issued by the Division of Manufacturing and Product Quality (DMPQ) in the Center for Drug Evaluation and Research (CDER) Office of Compliance and signed by DMPQ Director Richard Friedman.

The prominence of laboratory control issues in the four letters reflects their overall frequency in 483s issued to foreign firms, according to recent FDA data.

[FDA’s FY 2010 foreign drug GMP data on lab control problems and an analysis of the lab issues raised in the recent warning letters and the insight they provide on the agency’s concern with supply chain communications is provided for subscribers beginning on page 2. To subscribe to IPQ click here.]

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