Flying Insects and Chipping Paint: FDA Warns Chinese API Manufacturer
Posted 30 August 2016 | By
Two of Xinxiang Pharmaceutical’s China-based manufacturing facilities received a US Food and Drug Administration (FDA) warning letter on 19 August after FDA inspectors found drug manufacturing equipment and facilities in such a state of disrepair as to be unsalvageable.
The company, which previously received a Form 483 in 2015 and was placed on the import alert list in April, was found to be using “open equipment” for the manufacture of active pharmaceutical ingredients (APIs). FDA’s investigator “observed chipped paint on the ceiling directly above open [redacted], which could have fallen into your open equipment and contaminated your API.”
Flying insects were also observed in clean rooms and may have entered through gaps and holes around windows and doors, the letter says.
FDA adds that the company said it would repair parts of the facility and replace some equipment, though FDA says it did not provide details regarding such planned repairs and replacements, such as purchase orders and photographs of the renovations and replacements.
“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,” FDA adds. “In response to this letter, provide your written plans to renovate both facilities entirely, and submit photographic evidence of the completed renovations.”
FDA also recommended that Xinxiang engage with a third-party consultant qualified to evaluate the company’s operations to assist it in meeting current good manufacturing practice (CGMP) requirements.
“Failure to correct these deviations may also result in FDA continuing to refuse admission of articles manufactured in Xinxiang City, Henan, at Xinxiang Pharmaceutical Co., Ltd., No. 30 Jianshe West Road, Beigandao, and Xinxiang Tuoxin Biochemical Co., Ltd., at Muye and Deyuan Road cross street, into the United States,” the letter notes.