FDA 483 - Symbiotec Pharmalab Limited - July 05, 2019

Symbiotec Pharmalab Private Limited, an API manufacturer in Pithampur, Madhya Pradesh, India, was cited for significant deficiencies across its quality control and manufacturing operations. The inspection revealed failures in laboratory investigations for out-of-specification results, inadequate monitoring of critical process parameters, and deficiencies in cleaning validation master plans. Additionally, the firm was found to have inadequately performed equipment and production process qualifications and validations, including a lack of stability monitoring for API lots.