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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 201517Orig1s000 MICROBIOLOGY REVIEW(S) Product Quality Microbiology Review 10 MAY 2011 NDA: 201517 Drug Product Name Proprietary: N/A Non-proprietary:
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Microbiology review is a process conducted by the Food and Drug Administration (FDA) to evaluate microbiological data related to a specific product or process. It involves assessing the potential risks associated with microbial contamination and determining whether the product meets regulatory requirements.
Manufacturers and distributors of food, drugs, and medical devices are typically required to file a microbiology review with the FDA. This ensures that the products they produce or distribute are safe and free from microbial contaminants.
To fill out a microbiology review, you need to gather relevant microbiological data related to your product or process. This may include information on testing methods, microbial specifications, and results of microbial analysis. You can then submit this information electronically through the FDA's online portal, govfdaaccessdatawww.
The purpose of microbiology review is to assess the microbiological safety and quality of products regulated by the FDA. It helps to identify any potential risks associated with microbial contamination and ensures that products meet the necessary standards for regulatory compliance.
The information that must be reported on a microbiology review may vary depending on the specific product or process. However, it typically includes details on the testing methods used, microbial specifications, results of microbial analysis, and any corrective actions taken to address microbial contamination.
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