The FDA this week released a warning letter it sent to Chinese surgical garment and medical disposables maker Hubei Hongkang Protective Products after the agency was unable to complete an inspection at the firm’s facilities in Huanggang City, China.
Hubei Hongkang Protective Products produces surgical masks, conductive shoes and shoe covers, examination gowns, surgical suits, surgical dresses, surgical caps, scavenging masks, disposable medical bedding, surgical apparel accessories, non-surgical isolation gowns and impervious non-surgical isolation gowns, according to the FDA.
The federal watchdog warned that it would be taking steps to refuse entry to devices manufactured by the company due to the “serious nature” of its violations.
