BioSculptor Corporation – FDA Warning Letter, Nov 30, 2010

On March 9, 2011, the FDA issued a Warning Letter to BioSculptor Corporation following a November 29-30, 2010 inspection. The inspection revealed that the firm's CAMLab Cranial Orthosis Helmet and FastScan Laser, classified as devices, were adulterated under Section 501(h) of the Act, as their manufacture, packing, storage, or installation did not conform to the Quality System (QS) regulation (21 CFR Part 820).

The firm's December 16, 2010 response to the FDA 483 was deemed inadequate. Key violations included: 1. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)). 2. Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1)). 3. Failure to establish and maintain design validation procedures, including proper risk analysis documentation (21 CFR 820.30(g)). 4. Failure to maintain adequate complaint files and establish complaint procedures (21 CFR 820.198(a)). 5. Failure to establish and maintain procedures for changes to specifications, methods, processes, and procedures (21 CFR 820.70(b)). 6. Failure to establish and