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FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.
FDA issued a warning letter to USV Private Limited, dated March 10, 2017, in regard to an inspection of the company’s facility located at H-17/H-18, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman from June 1–10, 2016. The letter contains a list of current good manufacturing practice (CGMP) violations that FDA also found at another USV Private Limited facility in February 2014.
During the 2016 inspection, investigators found that the company had failed to establish proper laboratory controls and procedures to prevent microbiological contamination on sterile products. Environmental monitoring tests were not performed correctly or routinely, and smoke studies were not properly performed.
In addition, computer systems were found to not be appropriately controlled and data in laboratory records were not complete. The warning letter states that the company’s computer system allowed for the deletion of files and no backup file was maintained. Unrestricted access to a microbial identification instrument and external hard drives was also found. The agency recommended the company perform comprehensive data integrity remediation.
According to FDA, similar violations were found at the company’s Arvind Vithal Gandhi Chowk, BSD Marg, Govandi, Mumbai facility that resulted in a warning letter in February 2014. “These repeated problems at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate. Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements,” the agency stated in the 2017 warning letter.