An inspection of Malladi Drugs & Pharmaceuticals’s Unit 1 in the Tamil Nadu district of India in September last year resulted in the US Food and Drug Administration (FDA) issuing a warning letter earlier this month.
The active pharmaceutical ingredient (API) maker was found to have violated current good manufacturing practice (cGMP, including failing to use appropriate precautions to minimise the risk of API contamination in an open processing area.
“Parts of your facility in which API production is conducted are open to the outdoors,” the letter stated. “Our investigator observed vermin, such as birds and insects, in the facility near open equipment used for drug manufacturing. Their presence puts your drugs at risk of contamination.”
The firm was also found to have issues with the use and cleaning of its equipment:
“Your cleaning processes are insufficient. You lack justification that you can prevent contamination from foreign matter and other impurities that may seep from the (b)(4). Further, your equipment is difficult to reproducibly clean,” the Agency said.
Problems validating the reproducibility of the firm’s API production process were also addressed in the letter:
“During our inspection, you acknowledged that you failed to adequately validate your (b)(4) API drug manufacturing process. In addition, our inspection found that your process lacked adequate control during the (b)(4) step. Twenty-four batches yielded out-of-specification test results for an unspecified impurity over approximately two years. Your firm rejected these nonconforming batches and reprocessed some of them.”
The firm, which was placed on an import alert in December, has been advised to engage with an independent consultant to assist in remediating the problems highlighted by the FDA.