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Medical Devices / Inspections and Audits

Beverly Hills Breast Implant Practice Cited for QS Failures

Oct. 11, 2018

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 Form 483 following a July 7-13 FDA inspection.

The firm lacked a design plan documenting design requirements to address the intended use of the device. It had not conducted any risk analysis and no records were maintained to verify or validate design changes.

The breast implant was manufactured in a sterile room, but the firm had not implemented procedures to control environmental conditions to ensure sterility.

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