483
Eastern Cranial Affiliates, LLCFDA 483 - Eastern Cranial Affiliates, LLC - June 13, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Person
Open in Dashboard
ID · 96904422-65dc-4c9a-9f2b-eac37ce1130e