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The FDA cited Houston, Texas devicemaker Talon for a multitude of transgressions at its facility, including problems with validations and complaint investigations. Read More
CDRH released final guidance for device sponsors on requesting feedback or meetings with agency officials ahead of investigational device exemption (IDE) or other marketing submissions under the Q-Submission program. Read More
Failure to validate the design of its AED batteries, lax complaint handling procedures and numerous other quality system repeat observations resulted in a warning letter for AED maker Zeller Power Products following a Nov. 6-9, 2018 inspection of its Wallace, Idaho facility. The FDA said the firm’s response to the Form 483 was not acceptable. Read More
Failure to document re-worked nonconforming products and to establish procedures for controlling process parameters were just a few of the many quality system failures documented in a May 13 warning letter to devicemaker Orchid Orthopedic Solutions following a Feb. 4-15 inspection of its Holt, Michigan plant. Read More
Plano, Texas devicemaker Surgisil is in hot water with the FDA over its Perma Facial Implant, a device that is only cleared for cosmetic facial augmentation and augmentations in areas like the nose, chin and cheeks. Read More
CDRH released guidance on what information should be included in regulatory submissions for devices that generate quantitative imaging values. Read More
The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Read More
LC Medical Concepts’ sterilization operations were not adequately validated to demonstrate sterility of its wound therapy kits, an Oct. 16-23, 2018, FDA inspection of the devicemaker’s Rochester, New York, facility revealed. Read More
Failure to document numerous activities including validation, corrective and preventive actions, process changes and others landed Hyperbaric Technologies a Form 483 following a Sept. 19-26, 2018, inspection of its Amsterdam, New York, manufacturing facility. Read More
Healthcare company MedStar Health will pay $35 million to settle claims that it made illegal kickbacks to a cardiology group in exchange for referrals for various cardiovascular procedures including implants of medically unnecessary stents. Read More
Cincinnati, Ohio-based Full Range Rehab failed to file Medical Device Reports within 30 days of receiving information that one of its devices may have caused or contributed to a serious injury, according to a 483 issued to the firm following a Jan. 30-31 inspection. Read More