Eastern Cranial Affiliates, LLC – FDA 483, Jun 13, 2024

Eastern Cranial Affiliates, LLC in Fairfax, VA was inspected by the FDA from June 10-13, 2024, as a medical device manufacturer. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding complaint handling, equipment calibration, and internal quality audits. These issues indicate a lack of adequate procedures and implementation for critical quality control processes.