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FDA Inspections - How not to do it

Looking through the FDA's website, the section on Warning Letters is always worthy of a brief read. This is where you can find out which companies have received a proverbial slap on the wrist from the FDA, and in some cases more. Scanning through them today leads me to one which was issued on October 19, 2016 to an overseas Pharmaceutical company (Found here:

Rule number one of any inspection, be it FDA or any other Health Authority, do not deny them entry. Especially do not deny them entry, after they have seen something through a window, and requested to see that item specifically, only to let them in the next day when you have removed the item.

If you are unsure of what your obligations are under an inspection by a Health Authority, or if you would like to see how you would hold up during one, consultants can help by training your personnel and conducting mock inspections. It is better to know your deficiencies in advance, rather than be surprised.

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