Are the US FDA sleuths culturally insensitive? It seems so.

Of late, there has been a lot of discussion around US drug regulator FDA’s FD-483 notice. This is especially in the wake of a few Indian pharma companies receiving a warning letter on deficiencies found in inspections. The regulator issues such notices as part of its efforts to ensure quality of drugs under its Good Manufacturing Practices. In a way, it’s a performance audit.

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