483
Hearing Lab Technology, LLCHearing Lab Technology, LLC – FDA 483, Apr 20, 2023
Record Details
An FDA inspection of Hearing Lab Technology, LLC in Bristol, PA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish procedures for finished device acceptance, specifically for wireless functionality testing of their in-the-ear wireless hearing aids. Additionally, device history records lacked proper documentation and signatures for manufacturing and quality control steps.
View Company Profile
ID · 89079eba-3b02-4b78-a264-5100f6044f59
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.