Chinese Drug Manufacturer Gets Warning for Limiting FDA’s Inspection

A Chinese producer of drugs and medical supplies improperly limited the FDA’s inspection of its manufacturing facility, the agency said in warning letter.

Baoying County Fukang Medical Applicance Co. in Jiangsu Province, China, limited the Food and Drug Administration’s inspection by not providing information on its microbiological testing processes. Because the company limited the FDA’s inspection, drug products made at the facility are “adulterated” under the Federal, Food, Drug and Cosmetic Act. The warning letter, dated Dec. 8, was posted online Dec. 20.

The company was placed on an import alert on Sept. 20, the letter said, so ...