New and Revised FDA Import Alerts for June 5-6
On June 5-6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
99-34: Drugs or Medical Devices from Firms Without a Valid Drug or Medical Device Registration (here)
Block Scientific (United States) (Added 06/06/18)
- All In vitro diagnostic products (product codes beginning with 75, 81, 82, 83, 88, 91, 92)
68-19: Unapproved New Animal Drugs (here)
Honey Collection Ltd (New Zealand) (Added 06/06/18)
- Moisturizing (Skin Care Preparations) (53 L -- 06)
- Other Skin Care Preparations, N.E.C. (53 L -- 99)
- Miscellaneous Patent Medicines, Etc. (66 V -- 99)
99-32: Products from Firms Refusing FDA Foreign Establishment Inspection (here)
Guangzhou Topwork Chemical Co., Ltd. (China) (Added 06/06/18)
- All Drug and Drug Products (product codes beginning with 55, 56, 60, 61, 62, 63, 64, 65, 66)
89-08: Class III Devices Without Approved PMAs or IDEs and Other Devices not Equivalent or With no 510k (here)
Guangzhou Baiyun District Handaelectronics Factor (China) (Added 06/06/2018)
- Mole Removal Pen (Device, Electrosurgical, Cutting & Coagulation & Accessories) (79 G -- EI)
- Mole Removal Pen (General Medical) (80 L -- DQ)
Ropack, Inc. (Canada) (REMOVED from Red List 06/05/18)
- All medical devices (product codes beginning with 73, 74, 76, 77, 78, 79, 80, 84, 85, 86, 87, 89, 90)