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.
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 is manufactured in a sterile room, but the firm had not implemented procedures to control environmental conditions to ensure sterility. Inspectors observed contaminated surgical equipment and contaminated device components in the sterile room and said personnel entered the room freely without any restriction or gowning procedures. In addition, there were supply/return air vents above the manufacturing area and air supplied to the room was not filtered.
The firm fell short on process control procedures during manufacturing and it had not established procedures for evaluating and selecting suppliers and contractors. For example, it did not maintain records to demonstrate that the supplier of the polytetrafluroethylene sheets used to manufacture the implants were evaluated to ensure they met specifications.
The FDA cited the firm for other quality control lapses such as procedures for acceptance of incoming products, control of storage areas, and for receiving and reviewing complaints.
Read the Mark Berman Form 483 here: www.fdanews.com/10-03-18-markhberman483.pdf.