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This document details FDA inspection observations from 2016, highlighting compliance issues in API manufacturing facilities. It covers areas such as data integrity, microbial safety, and facility maintenance.
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What is fda inspection report?
An FDA inspection report is a document that summarizes the findings of an inspection conducted by the Food and Drug Administration to evaluate compliance with regulatory standards for food, drugs, medical devices, and other products.
Who is required to file fda inspection report?
Manufacturers, distributors, and other entities involved in the production and handling of food, drugs, and medical devices are required to file FDA inspection reports.
How to fill out fda inspection report?
To fill out an FDA inspection report, follow the guidelines provided by the FDA, ensure all relevant information about the inspected facility, products, and any findings are accurately documented, and submit the report in the specified format.
What is the purpose of fda inspection report?
The purpose of the FDA inspection report is to ensure compliance with established safety and quality standards, identify any violations or issues of concern, and guide corrective actions if necessary.
What information must be reported on fda inspection report?
The FDA inspection report must include details such as the facility name, location, type of products inspected, date of inspection, findings, observations, and any corrective actions required.
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