FDA 483 - Nutra Solutions USA, Inc. - April 09, 2019

Nutra Solutions USA, Inc. in Deer Park, NY, a dietary supplement manufacturer, received a Form 483 with multiple significant observations related to quality control and production processes. The inspection revealed failures in verifying finished product specifications, identifying dietary ingredients prior to use, and conducting proper material reviews for out-of-specification results and unanticipated occurrences. Repeat observations from a previous inspection indicate persistent issues with product testing and ingredient identity verification.