FDA WARNING_LETTER - Europharma Concepts Limited - November 03, 2017

The FDA issued a Warning Letter to Europharma Concepts Limited following an inspection from October 31 to November 3, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug product adulterated.

Key violations include: 1. **Failure to test components:** The firm failed to test glycerin for diethylene glycol (DEG) and ethylene glycol (EG) and other components for identity, purity, strength, and quality before use in manufacturing OTC (b)(4) Gel. The response was inadequate as the firm is responsible for identity testing and did not address DEG/EG presence in glycerin used for products already on the market. 2. **Inadequate production and process controls:** The firm failed to perform process validation for their (b)(4) Gel OTC drug product, meaning the manufacturing process was not demonstrated to be reproducible and controlled. The firm's cessation of manufacturing this product does not address unvalidated product already in the U.S. market.

The FDA requires Europharma Concepts to provide: * Written procedures for supplier qualification and component testing, including verification of supplier COAs and identity testing for every incoming lot. * A detailed risk assessment for glycerin-containing products within expiry in the U.S. market, including testing retain samples for DEG/EG and outlining corrective actions for out-of-specification results. * A comprehensive, independent review of laboratory practices and a detailed CAPA plan.