FDA WARNING_LETTER - Eastern Cranial Affiliates, LLC - June 18, 2010

On November 16, 2010, the FDA issued a Warning Letter to Eastern Cranial Affiliates, LLC, following a June 2010 inspection. The inspection revealed that the firm's KidCap Cranial Molding Orthosis devices are adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Violations include: 1. Failure to establish and maintain procedures for changes to procedures (21 C.F.R. § 820.70(b)), specifically regarding an unverified/unvalidated manufacturing change for the KidCap. 2. Failure to validate processes where results cannot be fully verified by inspection and test (21 C.F.R. § 820.75(a)), including unvalidated production changes for patient head measurement using a digital scanner and unvalidated mold production changes. 3. Failure to establish a quality plan relevant to device design and manufacture (21 C.F.R. § 820.20(d)). 4. Failure to conduct reviews of manufacturing procedures and appoint a management representative for quality system requirements (21 C.F.R. § 820.20(c