Black Mold, Corrosion, Bad Toilets and Trashed Documents Highlight Form 483

A Chinese drugmaker was storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes, FDA investigators found during a 483 inspection.

Nor did any of the handwashing and toilet facilities at the Jiangsu Hengrui Pharmaceuticals of Lianyungang, Jiangsu, have hot — or even warm — water for employees to wash with, according to the eight-observation Form 483.

Pallets of drugs set to be destroyed were also left in a non-secure location, the report noted.

The investigators also noted that “The Quality Unit lacks adequate control” over batch records, and “lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality and purity of drug products.”

The company did not respond to a request for comment.

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