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356h Form

356h Form

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Instructions and help about 356h form

[Music] after a hiatus of two years the u.s food and drug administration resumed its on-site inspections of drug manufacturing units outside its borders including china and india it has been following this practice to make sure that all the medicines which enter into the country follow the set standards most inspections were put on hold in march 2020 when the world was hit by the pandemic indian pharmaceutical companies on their part try to adhere to the norms as any departure may hit their export adversely in one such inspection at sun pharma's alone facility this month the u.s fda team issued a form 483 the next morning of 10th may the share price of sun pharmaceutical industries fell over 4 so apparently the form 483 and 10 observations made in it were not good news for the firm the company said that it was preparing a response to the observations which would be submitted to the u.s fda within 15 business days the food and drug administration has the responsibility of protec

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