483
APEX DENTAL SLEEP LAB LLCAPEX DENTAL SLEEP LAB LLC – FDA 483, Feb 22, 2024
Record Details
An FDA inspection of APEX DENTAL SLEEP LAB LLC in La Mesa, CA, a manufacturer of dental sleep devices, revealed significant deficiencies in its quality system. Observations included inadequate documentation of corrective and preventive actions, lack of procedures for rework of nonconforming products, and insufficient complaint handling processes. Additionally, the firm failed to include Unique Device Identifiers (UDI) on its finished medical device labels.
View Company Profile
ID · d65483dc-f3a0-44b5-8fdb-5761ba376898
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.