FDA 483 - Orchid Pharma Ltd. - February 18, 2025

Orchid Pharma Limited, an API manufacturer in Alathur, India, received a Form 483 with seven observations during an FDA inspection from February 10-18, 2025. The observations highlight significant deficiencies in cleaning validation, process validation, equipment qualification, raw material testing, cleaning procedures, data integrity for laboratory equipment, and GMP training for personnel. These issues indicate a lack of robust quality control and assurance practices impacting the quality and safety of APIs manufactured for the US market.