FDA Hands Warning Letter to STI Pharma for Deficiencies in Reporting Adverse Events
The FDA issued a warning letter to STI Pharma for serious violations of adverse event reporting requirements.
An inspection of STI Pharma’s facility in Langhorne, Penn. revealed that the company did not properly evaluate several of the ADEs it received nor did it have written procedures for detailing how adverse reaction reports should be evaluated.
The FDA said that the company’s reliance on contractors to carry out PADE reporting makes the agency “concerned about your firm’s fundamental understanding and implementation of PADE regulations.”