Indiana Accident News

Detriot, Michigan, Drug Plant Receives FDA Warning

According to Newsinferno.com, Detroit, Michigan drug plant Caraco Pharmaceuticals received an official Food & Drug Administration letter or warning due to the conditions of its manufacturing plant. A number of various problems were outlined in the warning letter, along with a statement that the FDA would be withholding all marketing approvals for drug products from the plant until issues are formally addressed and corrected.

The FDA has been stringent with several other drug makers recently in regards to quality issues and manufacturing violations. However, recent investigations and restrictions have involved a plant in India, not a United States manufacturer.

Caraco told the media that the company would respond to the points in the letter in the next two weeks. "The company is committed to working cooperatively and expeditiously with the FDA to resolve the matters indicated in its letter," the company said in a statement.

The letter was the result of a routine inspection held in the Detroit facility in May of this year. The results of the inspection were the inadequate and untimely investigation of certain incidents by the quality control unit at the facility contrary to the company's standard operating procedures. The FDA stated that some of these issues had been problems in the factory before and had not been addressed in the past.

Caraco Pharmaceuticals, a division of the fifth largest drug company in the world, Sun Pharmaceutical Industries, also stated that they had responded to the points cited in the letter, taken corrective steps to right wrongs, and written the FDA with details of the changes. However, the FDA seeks further proof and clarification before it will agree to approve future drugs produced at the plant.

Caraco makes and distributes a number of medications - both generic and company-owed - that treats diseases like hypertension, arthritis, epilepsy, diabetes, and depression.

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