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FDA Warning Letter
#1 · September 28, 2024, 4:14 pm
What are the major reasons for that companies get 483 letters from the FDA?
#2 · September 29, 2024, 4:36 am
There are a lot of reasons for getting 483 from FDA. I mentioned here few:
- SOP violation
- Lack of investigation of OOS, Deviation etc.
- Proper cleaning procedure is not established
- Drug products are not stored in appropriate condition
- Lack of Data integrity
- Contamination in production area etc.