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FDA warns 3 Korean firms for rule violations

2018/04/29 11:34

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SEOUL, April 29 (Yonhap) -- The U.S. Food and Drug Administration (FDA) has warned two South Korean cosmetics makers and one pharmaceutical company for their violation of proper manufacturing procedures.

According to the FDA website Sunday, the American food and drug regulator has issued warning letters to Cosmecca Korea Co., It'S Hanbul Co. and pharmaceutical giant Celltrion for their violations of current good manufacturing practice (CGMP) regulations.

In a warning letter sent to Cosmecca Korea in February, the FDA said the letter summarizes significant violations of CGMP regulations for finished pharmaceuticals.

"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act."

   The FDA inspected Cosmecca Korea's factory in Eumseong, about 130 kilometers southeast of Seoul, from Sept. 18 to 22, 2017.

The U.S. regulator said failure to correct these violations may also result in its continuing to refuse admission of articles manufactured at the plant into the U.S.

In addition, the FDA sent a similar warning letter to It'S Hanbul, saying the company failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

"Your firm could not provide raw data to verify that you performed microbiological finished product testing for your over-the-counter (OTC) drug products," it said.

The FDA inspected the plant of It'S Hanbul in Eumseong from Nov. 27-Dec. 1 last year.

Early this month, Celltrion received a notice from the FDA saying it will withhold approval of Celltrion's biosimilars Herzuma and Truxima. In late January, the FDA sent Celltrion a warning latter, requesting supplementary documents on its domestic production facility and manufacturing process following an inspection of the company's plant in June last year.

Herzuma, a biosimilar, is used to treat breast cancer and another biosimilar, Truxima, is for patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.

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