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
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