FDA 483 - Sparsha Pharma Usa Inc - September 04, 2025

Sparsha Pharma Usa Inc. in Oceanside, CA, received a Form FDA 483 with 10 observations during an inspection from August 25 to September 4, 2025, for its OTC drug and medical device manufacturing operations. The observations highlight significant deficiencies across laboratory controls, data integrity, quality systems, production records, and material warehousing, including repeat observations related to unverified spreadsheets and CAPA documentation. These issues indicate a systemic lack of adherence to cGMP and medical device quality system regulations, potentially compromising product quality and reliability.