FDAnews Drug Daily Bulletin

Contaminated Equipment, Lack of Inspections Earn Warning Letter for Taiwanese Manufacturer

Oct. 4, 2016

Cheng Fong Chemical received a warning letter from the FDA for dirty equipment, poorly maintained facilities and improper investigations into possibly tainted batches of active pharmaceutical ingredients.

In April, inspectors found filth, insects, unidentified wet material on the floors and foul odors in cold rooms used to store raw materials, as well as corrosion and leaks around drug manufacturing equipment, at the company’s Taiwan facility.

The agency also found that Cheng Fong Chemical had failed to inspect batches that may have been tainted by particulates.

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