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FDA describes detailed CAPA Procedure in Warning Letter
An FDA Warning Letter is a formal communication from the US Food and Drug Administration (FDA) notifying a company or individual of regulato...
Gap Assessment Schedule M
To conduct a **gap assessment** between the **old Schedule M** and the **revised Schedule M** of the **Drugs and Cosmetics Rules, 1945**, we...
Lab Data Integrity issues by US FDA
The significant violations of CGMP regulations for finished products, which are mentioned in the Warning Letter, are listed as follows: ...
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