In a recent FDA warning letter, the FDA upheld the import alert that banned a certain Indian drug company's products from the US market. The FDA's warning letter noted that the company did very little to bring its facilities up to GMP standards or that any remedial efforts were wanting. But I thought one point was noteworthy!
The Warning Letter stated that despite the Indian drug company's products (intended for the US) was not in compliance with US FDA's standards, the company stated that such products would be diverted to the Indian market instead. Per the FDA letter, "In your response, you state, "we have decided to divert the referred batches" to the domestic (India) market."
So I wonder how the FDA would react to this? If GMP compliance is about "do you get it that quality matters?" then this type of diversion seems to say "I care more about the money saving versus the improper batches."
Now we don't of course know the full details of whether the batches, though not fit for US purposes, were fit for Indian purposes and hence Indian law compliant. But I wonder just in general how it is perceived to the FDA that batches that are non-compliant for the US population are somehow OK for Indians?
In my work/training with clients on GMP compliance I routinely try to preach the "culture of compliance" and to me, this type of response (either alone or in combination with the other stated violations) doesn't show a good culture of compliance.
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