FDA 483 - Eastern Cranial Affiliates, LLC - June 13, 2024

Eastern Cranial Affiliates, LLC, a manufacturer based in Fairfax, VA, underwent an FDA inspection from June 10-13, 2024, resulting in a Form FDA-483 detailing three significant observations. The primary issue identified was the company's failure to adequately establish procedures for receiving, reviewing, and evaluating complaints. Multiple patient complaints concerning issues such as redness, altered head shape, indentations, sweating, and product odor were not properly documented in the firm's complaint records.

Secondly, the inspection found that procedures to ensure equipment calibration, inspection, and maintenance were inadequate. Critical manufacturing instruments, including heating equipment, vernier calipers, thermometers, and cranial scanning systems, were either used without proper calibration, lacked documented calibration records, or had no established calibration protocols. This deficiency could compromise product quality and safety.

Finally, Eastern Cranial Affiliates did not perform quality audits at defined intervals or with sufficient scope. There was a lack of documented training for the Quality Assurance Manager responsible for conducting audits, and annual internal audits consistently failed to cover all required quality system areas. To address these findings, Eastern Cranial Affiliates, LLC is required to implement comprehensive corrective actions to ensure full compliance with regulatory quality system requirements.