The FDA has fired off a strongly worded warning letter to Yag-Mag Labs Private Limited of India, hitting the API manufacturer with an import alert.
According to the FDA, the company's Hyderabad facility "was not adequately designed to facilitate cleaning and minimize the potential for contamination." Inspectors saw "residues and corrosion on processing equipment," leaky piping, standing water and unsanitary restroom facilities, among other observations.
The agency also slams the company for not having appropriate procedures or practices to prevent cross-contamination. "For example, prior to April 2011, you did not use cleaning logs and it was reported to our investigator, by your personnel, that no cleaning was performed," the letter states. In addition, no evidence exists that cleaning occurred "between batches or between product changeovers...for non-dedicated equipment." Non-dedicated equipment should be cleaned between production of different materials to prevent cross-contamination, the letter points out.
Yag-Mag responded to the FDA's findings July 18, admitting its facility "was not up to the mark of FDA..." and that corrective certain actions were needed, but yet completed. But this response didn't satisfy the FDA, which said it lacked sufficient corrective actions.
"We highly recommend that you hire a third party auditor with experience in detecting data integrity problems, who may assist you in evaluating your serious [current good manufacturing practices] deviations," the letter states. "Your firm's broad-based CGMP compliance issues will require significant remediation and substantial investment of time and resources."
The letter warns the company that until its manufacturing practices comply with cGMPs, it will remain under FDA import alert, meaning all articles manufactured by the company will be refused entry into the U.S.
- see the warning letter
Special Report: Frightening Phrases: Warning letter language to watch