'No Hand Soap in the Washrooms,’ Says Warning to Surgical Mask Maker

September 6, 2013

Hubei Weikang Protective Products, a Chinese manufacturer of surgical masks, did not provide hand soap in its washrooms, according to an FDA warning letter.

The company also lacked the “means for employees to dry their hands in a sanitary manner,” according to the Aug. 12 letter posted recently online. The FDA goes on to chide Hubei for failing to post procedures on the proper way to gown and wash up before entering the production area. The comments followed an April 1-4 inspection of Hubei’s Xiantao City facility.

During the inspection, an investigator saw certain equipment left uncleaned after its last use, noting “miscellaneous debris and dust.” The investigator also saw rolls of nonwoven material stored in the warehouse with no identification labels.

While labeling on Hubei’s surgical masks states that they meet international standard EN 14683 Type I or Type II, the company lacked documentation that the devices conform to the standard.

Meanwhile, Hubei’s corrective and preventive action (CAPA) procedure does not require the implementation, verification or validation of corrective actions. The company did not verify the two CAPAs generated since January 2012, the letter says.

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