Ohm Laboratories (Ohm), a wholly-owed subsidiary of Ranbaxy Laboratories, has received a warning letter from the FDA for its liquid manufacturing facility located in Gloversville, New York. The letter mentions certain cGMP violations based on site inspections conducted between July and August, 2009.
Reportedly, in order to effectively address such issues, Ohm has retained the services of PRTM, to provide expertise and advice on issues cited by the FDA at its facility in the US.
Earlier this year, the FDA has inspected two other plants of Ohm and did not observe any material deviation, said the company. These plants manufacture most of the products supplied in the US market.
The company is expected to continue to co-operate with the FDA to bring the matter to closure in a timely manner. Ohm said it remains committed in its efforts of being fully complaint with the US Regulatory standards, while offering affordable generic medicines to the US healthcare system.