FDA 483 - LNHC Inc. - January 16, 2026

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.