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The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Read More
The FDA issued a Form 483 to Baxalta after an inspection revealed a litany of observations including two from an earlier inspection that were not corrected. Read More
The FDA hit the Dongying Tiandong Pharmaceutical Co. with a warning letter for failing to investigate and document out-of-specification results when testing drug batches as well as GMP violations. Read More