2. Failure to properly maintain, repair, and keep clean buildings used in the manufacture of API in a manner that prevents contamination where open equipment is used.Unsalvageable -- that doesn't sound good. (I always wonder what photographic evidence will work for FDA. "Here's a picture of a new facility - done!")
You utilized open equipment for the manufacture of API. Our investigator observed chipped paint on the ceiling directly above open [redacted], which could have fallen into your open equipment and contaminated your API. Our investigator also observed gaps around windows and doors, and holes in ceilings directly above open [redacted]. Flying insects that were observed in clean rooms and on product transfer [redacted] may have entered through these gaps and holes.
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.
Wednesday, September 7, 2016
Warning Letter of the Week: flying insects edition
A happy epistle from the Center for Drug Evaluation and Research to Xinxiang Tuoxin Biochemical Co., Ltd. in Henan, China: