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On June 15, 2006, the US Food and Drug Evaluation?s Center for Drug Evaluation and Research (Rockville, MD) issued a 7-page warning letter to Ranbaxy Laboratories (Himachal Pradesh, India) for violations to US current good manufacturing practices.
On June 15, 2006, the US Food and Drug Evaluation's Center for DrugEvaluation and Research (Rockville, MD, www.fda.gov) issued a 7-page warning letter toRanbaxy Laboratories (Himachal Pradesh, India, www.ranbaxy.com) forviolations to US current good manufacturing practices (CGMPs).
Investigators found "significant deviations" to CGMP regulations duringa Feb. 20-25 inspection of the company's pharmaceutical manufacturingfacility in Paonta Sahib, India. Ranbaxy issued three responses (March20, April 20, May 25) to the observations noted in an InspectionalObservations (FDA 483) form at the end of the inspection, but FDA stillhas several concerns:
FDA said in its letter, "Until FDA has confirmed correction of thedeficiencies observed during the most recent inspection and compliancewith CGMPs, this office will recommend withholding approval of any newapplications listing your Paonta Sahib facility as the manufacturer offinished pharmaceutical drug products."