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Agency officials noted that airborne particulate monitoring results exceeded the action limit on two occasions, but the investigation was not fully documented. Read More
Sterile devices were handled in a cleanroom with inadequately defined environmental controls, FDA inspectors found in an inspection of a Centurion Medical Products facility in Howell, Michigan. Read More
Failure to investigate complaints about devices that did not meet specifications and other serious quality system deviations landed Respire Medical Holdings an 11-item 483 following an FDA inspection of its Brooklyn, New York facility. Read More
The FDA sent a warning letter to American Contract Systems for process validation violations at its Houston, Texas medical device manufacturing and sterilizing facility. Read More
Corrective actions by Integra Neurosciences may have affected the integrity of its external drainage systems and led to a cerebrospinal fluid leak, FDA inspectors found during an inspection of the firm’s Anasco, Puerto Rico plant. Read More
A user facility adverse event was filed with the FDA, but no information was available in the service report concerning the medical impact on the patient, the agency said. Read More
The firm’s production processes were “not conducted, controlled and monitored to ensure that a device conforms to its specification,” the agency said. Read More
Environmental Tectonics: A litany of good manufacturing practices lapses related to documentation and validation resulted in a seven-item Form 483 for Environmental Tectonics following an inspection of its Southampton, Pennsylvania facility. Read More