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Cair LGL, a manufacturer of medical devices and equipment for hospitals, failed to properly submit MDRs, adequately maintain complaint files or evaluate complaints, the FDA said following a February inspection of its facility in Lissieu, France. Read More
In a warning letter to Becton Dickinson Medical System, the FDA said the devicemaker must further document its corrections to problems with environmental conditions and safeguards against contamination. Read More
The complaint said the device’s bullet tip fell off during a surgical procedure and had to be removed from the patient through medical intervention. Read More
Failure to establish a design history file for its Pocket Protector breast implant pouch, landed the Beverly Hills practice of breast augmentation surgeon Mark Berman a 15-item 483 following a July 7 to July 13 FDA inspection. Read More
Failure to report a voluntary recall to the FDA landed Respire Medical an FDA Form 483 following an April 24 to May 2 inspection at its Brooklyn, New York facility. Read More
FDA inspectors said the firm had not established records that described quality control procedures to monitor aluminum equivalence attenuation within its surgical C-Arm tables. Read More
The firm also failed to adequately maintain one of its device master records, as it was unable to provide the DMR specification for the chemical makeup of silicone material used in the firm’s ultra-soft silicone products. Read More
The FDA flagged six devicemakers for a variety of deficiencies including complaint handling, inadequate documentation and quality system failures. Read More