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Manufacturing Compliance Updates In Brief: A Reduced Focus On Data Integrity

Executive Summary

US FDA has issued at least 10 GMP warning letters in February and March to drug and API manufacturers in China, India, France, South Korea, Hong Kong, the Dominican Republic and the US. Common problems seen are failure to validate manufacturing processes, inadequate testing to conform that products meet specifications, and inadequate safeguards to prevent microbiological contamination, yet in a recent turn, only a few manufacturers had data integrity problems. FDA posts Form 483 reports issued to four manufacturers in India for GMP violations and adds six facilities to its drug GMP import alert.


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