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FDA warns Baxter about its 2 facilities in PRico

FDA warns Baxter about its 2 facilities in PRico

Baxter International Inc., a medical products and services company, is addressing concerns cited in a warning letter from the U.S. Food and Drug Administration regarding two of its facilities in Puerto Rico, the company's spokeswoman said Thursday.
The letter focuses on good manufacturing practice violations at the plant in Jayuya, and on the distribution of materials to help customers with certain nutrition products, spokeswoman Deborah Spak said.
The letter also cites failure to submit post-marketing reports in another plant in Guayama, she said in a statement.
Spak said the concerns have not led to any serious adverse events but declined further comment about the letter's contents.
"Baxter continues to manufacture the products referenced, which continue to be safe and effective if used in accordance with the labeled instructions," she said.
FDA spokesman Christopher Kelly said the warning letter has not been posted on the agency's website and that he did not immediately have access to it.
Baxter is based in Illinois and has three manufacturing facilities in Puerto Rico.


Updated : 2021-05-10 02:02 GMT+08:00