The FDA issued a warning letter to STI Pharma for serious violations of adverse event reporting requirements. 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
Hoggan Scientific LLC has been hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues. Read More
Circle Prime Manufacturing received a Form 483 after an FDA inspection revealed inadequate records, complaint procedures and a failure to describe its vendor rating criteria. Read More
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More
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