The FDA issues warning letters when a company breaks the FDA regulations. They usually send warning letters after FDA inspection and find big problems that can cause serious health issues to consumers. Warning letters contain information for the company like recall of products from the market or stop ...

Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978. After that a lot of document guidelines are published on cleaning validation and nowadays cleaning validation is the main focus area of FDA GMP inspections. In ...