Literature review and Safety Evaluation || Six Sigma II Project Management
Recently during an inspection from 9th Apr to 17 Apr 2024 USFDA issued a Form 483 with five inspectional observations to Marksans Pharma’s manufacturing facility in Goa. This form is issued at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the food drug and cosmetic act and related acts. However, the company has committed to addressing these observations within the stipulated time. This incident emphasizes the importance of regulatory bodies like the CDSCO in maintaining the quality of drugs in the market. The role of CDSCO is critical in maintaining and improving the quality of drugs in the Indian market. Incidents like this one highlight the need for stringent regulatory oversight to ensure the safety and efficacy of drugs. #FDAINSPECTION #FORM483 #REGULATORYCOMPLIANCE