483
LNHC Inc.FDA 483 - LNHC Inc. - January 16, 2026
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
LNHC Inc. in Durham, NC, was issued a Form 483 following an inspection from January 12-16, 2026. The firm failed to conduct required annual product quality reviews for its active pharmaceutical ingredient (API) since commercial production began in June 2023. This lapse impacts numerous batches that have been released or destroyed without systematic review to verify process consistency.
Open in Dashboard
ID · c4336315-7c32-4cc6-807d-169da7add4fc