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

Source: https://www.globalkeysolutions.net/records/483/eastern-cranial-affiliates-llc/96904422-65dc-4c9a-9f2b-eac37ce1130e

> FDA 483 for Eastern Cranial Affiliates, LLC on June 13, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eastern Cranial Affiliates, LLC
- Inspection Date: 2024-06-13
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: 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.

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/eastern-cranial-affiliates-llc/34286952-2212-4ad7-b250-b3b9585ab87d

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64