Biosil saline breast implant 510(k) on hold due to GMP deficiencies -- FDA warning letter.
This article was originally published in The Gray Sheet
Executive Summary
BIOSIL GMP PROBLEMS STALLING 510(k) FOR SALINE-FILLED BREAST IMPLANTS, FDA tells the firm in a Dec. 24 warning letter. FDA says that it will not clear Biosil's 510(k) for a saline-filled breast implant until the company corrects good manufacturing practices violations observed at its Cumbernauld, Scotland facility during a pre-clearance inspection for the submission. The agency says that a reinspection of the facility will be needed to verify the corrections.