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The FDA is faulting a clinical investigator for neglecting to follow the established procedures for a trial testing a new investigational drug. Read More
Lima & Pergher Industria failed to provide stability data to ensure its drug products’ expiration dates and did not perform microbiological testing on each finished product, the FDA said in a warning letter to the Brazilian company. Read More
The FDA issued a 483 to Glades Drugs after an inspection revealed that three adverse event reports were associated with Vitamin D3 supplement capsules. Read More
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More