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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
ITG-Medev failed to follow up on its promised solutions to nonconforming process validations and documentation of acceptance activities, the FDA said in a warning letter to the devicemaker. Read More