Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Madhu Private Limited, A-260, Okhla Industrial Area, Phase-1, New Delhi, India, into the United States under section 801 of the FD&C Act, 21 U.S.C. 381. Articles under this authority that appear to be adulterated or misbranded are subject to detention or refusal of admission.