483
Choice Spine LLCFDA 483 - Choice Spine LLC - September 30, 2019
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
Choice Spine LLC, a human tissue distributor in Knoxville, TN, received an FDA Form 483 for failing to perform and document corrective actions. The firm did not address or investigate a malfunctioning freezer temperature probe, which resulted in a two-week period where proper storage conditions for distributed product could not be accurately monitored. This lapse indicates a failure in maintaining adequate quality control over product storage.
Open in Dashboard
ID · bb29e972-ca86-4bff-bf99-261dabb5d317