The agency has given them a 15-day period to respond with a written explanation, along with the supporting documents they have been asked to submit, in person or through a duly authorised representative.
In the same notice, the FDA has laid out eight points it expects the three actors to act on immediately.
Finally, the FDA has asked the three actors to submit a written explanation as to why legal action should not be initiated against them for the prima facie violations of the aforesaid provisions of law.
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Written by Skyc Media Editorial
checkSenior Editorial Lead • Skyc Media
