Zhejiang Novus Pharmaceuticals Co. Ltd.: Vancomycin Hydrochloride

Drug, and Cosmetic Act for Vancomycin Hydrochloride for Injection, 500 mg/vial, 1 gram/vial, 5 gram/vial, and 10 gram/vial.

Pharmaceuticals Co., Ltd. FEI: 3013567704 manufacturing facility at Zhejiang, China, for this application, our field investigator observed objectionable conditions at the facility and conveyed that information to the representative of the facility at the close of the inspection.

Satisfactory resolution of the remaining objectionable conditions, and verification by the FDA, is required before this application may be approved.

In any resubmission of this application, please submit revised draft carton and container labeling that contains the following revisions:

Please note the amendments dated May 11, 2018 and May 25, 2018, were not reviewed during this review cycle.