FDA 483 - Mentha & Allied Products Private Ltd. - September 25, 2024

Mentha & Allied Products Private Limited received a Form 483 following an inspection that revealed significant deficiencies across multiple areas of its active pharmaceutical ingredient (API) manufacturing operations. Key issues include a dysfunctional Quality Unit, inadequate data integrity controls, poor complaint handling, insufficient personnel training, and failures in equipment validation, process validation, and material control. The observations highlight a systemic lack of adherence to cGMP principles, posing risks to product quality and regulatory compliance.