US FDA issues warning letter to Smruthi Organics

Smruthi Organics Ltd, a manufacturer of pharmaceutical ingredients, veterinary drugs, drug intermediates and photography developing chemicals, has received a warning letter from US Food & Drugs Administration (FDA) for its manufacturing unit in Solapur, Maharashtra.
Smruthi Organics Ltd has informed BSE that the US FDA has issued a warning letter for company's site located at Solapur with reference to the observations of inspection performed in October, 2013. The company stated that it was working with US FDA to resolve the issues.
 
As reported by B2B Connect earlier, Smruthi Organics received Form 483 from US FDA in October 2013 for violations of manufacturing norms at its Solapur plant. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management.  Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.