Ranbaxy has come up short in its responses to the FDA regarding GMP violations. A late December warning letter recently posted to the FDA Internet site says that the drug maker's "attempts to make global corrections after past regulatory actions have been inadequate."
The warning letter follows the inspection of an Ohm Laboratories plant in Gloversville, NY, last summer; Ohm is the U.S. arm of the generics maker. The FDA acknowledges a September response from the company, but said it "lacks sufficient corrective actions." The regulator received additional responses from the company in October, November and December.
The warning letter 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.
Other discrepancies, stability testing procedure violations, SOP inadequacies, and lack of documentation are among other violations cited in the letter.
- here's the warning letter