Chinese Facility Receives Warning Letter

September 1, 2016

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

On August 19, 2016, FDA sent a warning letter to Xinxiang Tuoxin Biochemical regarding current good manufacturing practices (CGMP) deficiencies observed during inspections of two of the company’s facilities in September 2015. Observations included improperly maintained equipment and facilities. Both facilities were placed on Import Alert 66-40 on April 6, 2016, according to FDA.

FDA inspectors visited the Xinxiang Pharmaceutical Co., Ltd., facility at No. 30 Jianshe West Road, Beigandao, on Sept. 14 and 16, 2015. Xinxiang Tuoxin Biochemical Co., Ltd., at Muye and Deyuan Road cross street, was inspected on Sept, 15, 17, and 18, 2015. During the inspection, investigators found non-dedicated drug manufacturing equipment not properly maintained. Product contact surfaces and reactors contained product buildup and chipped paint. “The documented state of disrepair demonstrates that you have not implemented an adequate preventive maintenance program. Although you have preventive maintenance schedules, our investigator found that for those preventative maintenance activities you state were conducted, you do not have records documenting their performance, and those records you did have lacked sufficient detail,” FDA stated in the letter.

The company was also cited for not properly maintaining and repairing buildings where API is manufactured. Open equipment was used to manufacture API, and investigators saw chipped paint on the ceiling above open equipment. Gaps around windows and doors and holes in the ceilings were also observed. The inspectors saw flying insects in cleanrooms and on product transfer. FDA commented on the company's response to their original observations, saying, “In your response, you stated that you would repair parts of your facility and replace some of your equipment. You did not provide details regarding your planned repairs and replacements, such as purchase orders and photographs of the renovations and replacements. As indicated above, at the time of our inspection, your facilities and equipment were in such a state of disrepair as to be unsalvageable; small or minor repairs will not adequately correct the problems and prevent their recurrence. In response to this letter, provide your written plans to renovate both facilities entirely, and submit photographic evidence of the completed renovations.”

FDA recommended the company hire a third-party consultant to evaluate their operations and reserves the right to withhold approval of any new applications or supplements that list either facility as a drug manufacturer.

Source: FDA