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.
“As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected,” the FDA wrote in its warning letter.
The Agency offered the business 15 days from the date it received the warning letter to correct its actions or to indicate steps it was taking to correct the failed inspection.