FDA Issues Warning Letters to UCSF and Par Health Over Environmental Monitoring Failures
The U.S. Food and Drug Administration (FDA) has issued warning letters to the UCSF Radiopharmaceutical Facility and Par Health due to deficiencies in their environmental monitoring practices. During an inspection of the UCSF facility, which produces radiopharmaceutical tracers, the FDA found that the quality unit failed to investigate multiple environmental monitoring results that exceeded action limits. Additionally, the facility did not adequately investigate several failing sterility test results. The FDA emphasized the importance of environmental monitoring for radiopharmaceuticals, which have short expiry periods and are often administered before sterility test results are available. The agency warned that losing environmental control in aseptic manufacturing could pose serious hazards to patients. UCSF has been asked to conduct an independent assessment of its environmental monitoring program. Similarly, Par Health, a company formed from the merger of Mallinckrodt and Endo, was found to have inadequa... 
