FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. Read More

Numerous validation studies were found lacking during an FDA inspection of and numerous Synapse Biomedical’s Oberlin, Ohio facility. Read More

An FDA inspection of hypodermic needle and syringe manufacturer MRP of Nashville, Tennessee found inadequate design verifications and root cause analyses for nonconforming products. Read More

Failure to establish and document finished device acceptance procedures and to adequately calibrate equipment were among the quality deviations that the FDA observed during a Sept. 15-21, 2020 inspection of Kenlor Industries’ Santa Ana, California facility. Read More

When undergoing an FDA inspection of a manufacturing plant, complying with agency requests and professional interactions with the investigators are the key, a panel of former FDA investigators advised during the 15th Annual FDA Inspection Summit hosted by FDAnews. Read More

Medical Device Single Audit Program (MDSAP) activities have continued during the COVID-19 pandemic, forcing auditors and device manufacturers to adapt to a virtual environment. Read More

The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More

The FDA continues to issue warning letters for unapproved products to treat or detect COVID-19 and said it is taking “urgent measures” to protect consumers from products that, without the agency’s approval or authorization, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Read More

The FDA issued a warning letter to Batelle Memorial Institute in Columbus, Ohio, for its Critical Care Decontamination System, which received an Emergency Use Authorization on March 28. Read More