FDA WARNING_LETTER - Beekley Corporation - May 03, 2012

On June 11, 2012, the FDA issued a Warning Letter to Beekley Corporation following an inspection from April 16 to May 3, 2012, which found their Bella Blanket device to be adulterated and misbranded. The inspection revealed violations of Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints to determine if Medical Device Reporting (MDR) was required (21 CFR 820.198(a)(3)). For example, the firm received 11 complaints of artifacts from December 2011-January 2012 but did not obtain necessary information (e.g., need for repeat mammograms, potential for misdiagnosis) to determine if an adverse event report was required. The firm's response did not include a revised complaint procedure. 2. Failure to ensure each lot of finished device met acceptance criteria before release (21 CFR 820.80(d)(1)). Prior to April 2012, no inspection was performed on Bella blankets to assure material did not interfere with image quality. 3. Failure to document results of finished acceptance activities (21 CFR 820.80(e)(3)). Although a "