Phrase: "We find inconsistencies"
From: Warning letter NYK 2010-07 to Ohm Laboratories
The FDA wrote Ohm regarding a July 13 through August 12, 2009 inspection of Ohm's manufacturing facility in Gloversville, NY. The warning cites Ohm for not thoroughly investigating a batch failure of its metformin HCI oral solution. The company failed to find a root cause for the failure and proposed that particle contamination originated from food-grade nozzle seals on the filling machine, according to the letter.
"We find inconsistencies between the description of the investigation in your response and our review of the investigation, which attributed a root cause to the failures. In addition, we have determined your investigation to be inadequate." The regulator also found that the company's investigations into fiber and cardboard particle contamination of three batches of another solution were inadequate.