FDA Warning Letter. Caraco Pharmaceuticals has received a Food & Drug Administration (FDA) warning letter because of conditions at its Detroit, Michigan plant. The FDA is withholding all future marketing approvals for medicines manufactured at the plant until the problems cited in the letter are corrected.
The letter, dated October 31, followed an inspection held at the company’s manufacturing facility in Detroit, Michigan which was initiated in May 2008.
The problems cited in the warning letter included 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 considered some of the observations to be repeat observations.
Caraco said it had responded to observations made by the agency and took corrective actions. Additional letters to the agency also noted improvements.
Until the Company’s responses to the observations have been clarified and explanations provided to the satisfaction of the FDA, the agency said it may, in the near term, withhold approval of pending new drug applications listing the facility as the manufacturer.
Caraco said it intends to respond to the FDA within 15 business days
Caraco said it intends to respond to the FDA within 15 business days. “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.
Caraco Pharmaceuticals is a division of Sun Pharmaceutical Industries, Ltd., the fifth largest pharmaceutical. Caraco manufactures and distributes a variety of generic and private label medications intended to treat a variety of disorders including hypertension, arthritis, epilepsy, diabetes, antipsychotic, depression and pain management.
Caraco is just the latest Indian drug maker to be cited by the FDA for quality problems. In September, the agency banned 30 Potentially defective generic drugs made at two Ranbaxy Laboratories plants in India.
The FDA’s decision to ban imports from the two Ranbaxy factories was made because of the agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at the facilities. Officials said they are concerned about whether the practices employed at the facilities could ensure purity of drugs they made.
In addition to the import alert, the FDA also suspended approval of any drug applications that list the two suspect Ranbaxy plants as a source of ingredients.