Ohm Laboratories Inc (Ohm), a wholly owned subsidiary of Ranbaxy Laboratories Limited, has received a Warning Letter, dated December 21, 2009, from the USFDA, for its liquid manufacturing facility located in Gloversville, New York, USA. The letter, inter alia, mentions certain cGMP violations based on site inspections conducted between July and August, 2009.
The Gloversville, NY facility is one of the three US-based manufacturing sites of Ohm Laboratories Inc.
In order to effectively address such issues, Ohm has retained the services of PRTM, Inc, a global consulting firm, to provide expertise and advice on issues cited by the US FDA at its facility in the USA.
Earlier this year, the US FDA had inspected two other plants of Ohm and did not observe any material deviation. These plants manufacture most of the products supplied in the US market.
The Company will continue to cooperate with the US FDA to bring the matter to closure in a timely manner and remains committed in its efforts of being fully compliant with the US Regulatory standards, while offering affordable generic medicines to the US healthcare system.
Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the U.S. healthcare system.