FDA warns Ranbaxy U.S. unit
This article was originally published in The Tan Sheet
Ohm Labs' liquid manufacturing plant in Gloversville, N.Y., draws an FDA warning letter for good manufacturing practice deviations. The subsidiary of Indian pharma Ranbaxy acknowledged receiving the letter in a Dec. 24 release, adding the GMP violations were discovered during FDA inspections in July and August 2009. FDA found two other U.S. Ohm plants compliant during 2009 inspections, the North Brunswick, N.J., firm said. Ohm sells and distributes private-label and OTC products in the U.S
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FDA sends a follow-up warning letter to Ohm Laboratories regarding several good manufacturing practice violations. The agency identified the violations during a July and August 2009 inspection of the company's Gloversville, N.Y., facility. The OTC manufacturer, a subsidiary of Indian pharma Ranbaxy, insufficiently addressed the violations in a Sept. 11 letter, the agency said in its Dec. 21 warning. Specifically, the company's methods, facilities or controls used to manufacture, process, pack and/or hold products do not conform to GMP regs. For example, the firm failed to identify a conclusive root cause for the contamination of several products and did not extend the investigation into batches of similarly treated products. FDA seeks an immediate response from Ohm or else it will seek legal action. Ohm acknowledged receiving the initial warning in a Dec. 24 statement (1"The Tan Sheet" Jan. 11, 2010, In Brief)
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