Ningbo Unichem Bio Technology Co., Ltd.

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

FDF4APIGMP

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).