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FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

DOCUMENTATION ISSUES IN PRODUCTION AND THE LABORATORY LEAD TO UNIMARK REMEDIES LTD RECEIVING A WARNING LETTER FOR API ADULTERATION

November 4, 2015 By Barry Friedman Leave a Comment

During March 18-21, 2014 the FDA inspected the pharmaceutical manufacturing facility, Unimark Remedies Ltd., located at 337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District, India. The FDA identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). These deviations caused … [Read more...]

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