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Among other observations, the FDA investigator found a lack of evidence demonstrating if a sterile barrier is maintained in packaging when the product is stored under worst-case conditions. Read More
Corrective and preventive actions were also found to be inadequate because they didn’t ensure that the root cause of nonconformances was identified during investigation, the Form 483 said. Read More
The FDA investigator noted that the device history record showed several instances in which a urine-dipstick control failed quality testing and acceptance testing was not documented but the product was packaged and released. Read More
FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. 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