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New Warning Letters in US Focus on Process Validation and Sponsor/Contractor Relations

Oct 28th, 2010

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Drug GMP warning letters issued in mid-October to Hauppage, New York-based Contract Pharmacal and to Advanced Testing Laboratory in Cincinnati, Ohio shed light on FDA’s compliance expectations for two front-burner issues – process validation and sponsor/contractor communications.

Both of the warning letters reference inspections completed in April.

FDA’s New York District placed the validation issues in the forefront of the letter to Contract Pharmacal – a manufacturer of a large number of prescription and OTC drug products and dietary supplements.

The district highlighted the investigation finding that the firm had “not established written procedures for or conducted appropriate validation studies” – in particular, for its caffeine 100 mg tablets, acetaminophen 500 mg/pamabrom 25 mg tablets, diphenhydramine HCl 25 mg capsules, and methenamine mandelate 500 mg tablets.

[An analysis of the two warning letters and the insight they provide on FDA’s expectations for process validation and sponsor/contractor communications is provided for subscribers beginning on page 2.  To subscribe to IPQ click here.]

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