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

FDA investigators found various quality system lapses during inspections at five device facilities, including failure to fully investigate complaints and to submit medical device reports, among other deficiencies. Read More

FDA hit Columbus, Ohio-based Battelle Memorial Institute with a warning letter for failure to comply with terms of its Emergency Use Authorization (EUA) for its decontamination system used for N95 respirators. This marks the first warning letter FDA has sent out regarding a product with a COVID-19-related EUA. Read More

Numerous bugs were reported related to IT Synergistics’ LifeTec Elite version 1 and 2 blood establishment computer software but were not documented as complaints and weren’t investigated, according to a 483 the firm received following a March 5-6, and June 23 FDA inspection of its Flowood, Mississippi facility. Read More

Failure to submit a field report to the FDA, and failure to submit medical device reports were just two of the 13 quality lapses that dogged specification developer Craftmatic Industries found during an FDA inspection at its Pompano Beach, Florida facility. Read More

The FDA found orthopedic devicemaker BioSculptor’s production processes were “not developed, controlled and monitored to ensure that a device conforms to its specifications,” according to a 483 the firm received following an FDA inspection at its Hialeah, Florida facility. Read More

Inadequate design validation procedures and a lack of environmental controls were among the quality system lapses observed during an FDA inspection of Pegasus Research’s Santa Ana, California facility. Read More

Inadequate corrective and preventive action procedures and failure to implement written medical device reporting (MDR) procedures landed Pan Medical a 483 following an inspection at the firm’s Largo, Florida facility. Read More