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FDA Updates
Recently, the Food and Drug Administration (FDA) began publishing periodic updates to Import Alert 86-07 to identify additional Chinese and Taiwanese companies that are now subject to “Detention Without Physical Examination” relating to imports of impact-resistant lenses in eyeglasses and sunglasses, also known as the "Red List."
Recently, the FDA sampled several children’s sunglasses and adult prescription lenses from certain foreign manufacturers, subjected them to the impact-resistance test (the drop ball test) and concluded that a large number of the tested lenses failed. In turn, because these shipments were accompanied by impact resistance certificates stating that the lenses passed the drop ball test, the FDA considers them misbranded and adulterated merchandise.
As a result, all shipments from the following companies will be detained automatically by the FDA, and those manufacturers will only be removed from the detention list if information is provided to the FDA to adequately demonstrate that the manufacturer has corrected the problem so that the FDA can be assured that future entries will comply with the drop ball test. The companies include:
China
- Coomex Source Limited, Guagfa Mansion, 42# Shangdong Rd., Quingdao
- Danyang San-Sino Optical Co., Ltd., Glasses Industrial Park, Danyang City, Jiangs
- Sunfree Enterprise Co., Ltd., 2nd Industrial Estate Shi-Ling, Guangzhou
- Tzong Rong Optical Co., Ltd. Industrial Development Area, 107 Country Road West, Shihling Town, Hua-Du City, Guangdong
- Wenzhou Ouhua Foreign Trade Corp., 2/F Block A Shuang Lian Bldg., Xiao Nan Road, Wenzhou
- Zhenjiang Wanxin Optical Co., Ltd., No. 25 Guangming Middle Road, Situ Town, Danyang City, Jiangsu
- Glory International Trading Inc., No. 81 Daging Road, Advanced Technology, Tangsh
- Pilot Optics International Corp., Ltd., Wenzhou 6th Floor, Guo-da Plaza, Airport Road , Wenzhou
- Taizhou Weifeng Glasses Co., LTD., Dubei Road, Duqiao Town, Linahi
- *New* Guangzhou Universal Optical Products Co., Ltd., No. 2 Industry Area, Lion Hill Town , Huandu Area, Guangzhou
Taiwan
- Hang Chow Industrial Co., Ltd., 9f 253 Chungsiao E Rd. Sec 3, Taipei
Even though this Import Alert identifies a specific group of companies, all importers of lenses, reading glasses and sunglasses must be mindful of the fact that any FDA district can sample shipments and then detain products if the lenses are not in accordance with 21 CFR 801.410. As the FDA states in the alert, “[s]urveillance of all impact-resistant lenses in eyeglasses and sunglasses from all countries is warranted.”
Importers of lenses, sunglasses and reading glasses should remind their manufacturers of the obligation for testing for impact resistance. The Import Alert reminds that all shipments of lenses, readers and sunglasses must be accompanied by a batch certificate showing compliance with the impact resistance test (found at 21 CFR 801.410(g)), and that the certificates must establish that the lenses meet the AQL of 6.5 when tested via the drop ball test. Shipments of products that fail to meet that level, or which do not include a certificate, are subject to refusal of admission into the commerce of the United States.
For more information, please contact Rick Van Arnam, The Vision Council regulatory counsel at rvanarnam@barnesrichardson.com.
