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The FDA warned a drugmaker in the Dominican Republic for significant good manufacturing practice violations including maintaining incomplete test data and faulty analytical methods. Read More
Health Canada issued an updated risk classification guide to ensure consistent decisions by agency inspectors when classifying GMP observations by risk and assigning overall compliance ratings to an inspection. Read More
The FDA issued Malladi Drugs & Pharmaceuticals a warning letter for significant good manufacturing practice failures at an active pharmaceutical ingredient facility in Tamil Nadu. Read More
The website claimed the product could be used with chemotherapy for the “clinical dietary management of the metabolic imbalances associated with glial tumors. Read More
The FDA warned a French drug contract testing laboratory following a September inspection that revealed deficiencies in testing practices and discrepancy investigations. Read More
The FDA issued Nan San Pharmaceutical a warning letter for significant violations of CGMPs, including a failure to test product batches and inadequately labeling of product expiration dates. Read More
During a September inspection at the firm’s Hong Kong facility, the inspector noted that the firm did not test all batches of over-the-counter topical liquid analgesics before batch release. Read More
The FDA issued Nan San Pharmaceutical a warning letter for significant violations of CGMPs, including a failure to test product batches and inadequately labeling of product expiration dates. Read More
Four firms in Switzerland, the United Kingdom and the U.S. were hit with Form 483s for having inadequate cleaning and sanitization procedures, in addition to batch record issues. Read More
The FDA warned five firms in South Korea, China and Germany for various GMP violations, including problems with sanitation, facility procedures and complaint handling. Read More