FDA 483 - Terra Pharma Labs, Inc - November 08, 2023

An FDA inspection of Terra Pharma Labs, Inc. in Irving, TX, a manufacturer of dietary supplements, revealed 12 significant observations related to fundamental deficiencies in quality control and record-keeping. The firm failed to establish product specifications, conduct raw material testing, maintain lot traceability, and implement essential written procedures for manufacturing, packaging, labeling, holding, distribution, and sanitation. These findings indicate a severe lack of adherence to regulatory requirements for dietary supplement production.