FDA finds too many flies in Ranbaxy’s sample storage room

FDAThe U. S. Food & Drug Administration (FDA) slapped an import ban on Ranbaxy Laboratories Ltd's Toansa plant after it observed several lapses, including too many flies in the sample storage room, the regulator's inspection report states.

According to the report, the FDA found at least eight lapses at the plant that forced the regulator to prevent Ranbaxy drugs from entering the U. S. market. Too many flies and broken and un-closeable equipment and documentation storage cabinets were among the lapses.

The report states, "Too Numerous to Count (TNTC) flies were observed throughout the sample preparation room, and laboratory reagent/equipment/documentation storage cabinets were found to be broken and uncloseable."

The report addes that raw materials, intermediates and finished active pharma ingredients (APIs) analytical results failed to comply with the regulator's set standards. Consequently, the regulator banned imports of drugs produced at the Toansa plant until acceptable results are obtained.

The audit team underlined that Ranbaxy repeated the same errors that were cited by the U. S. regulator in its earlier inspection conducted in December 2012. Previously, the U. S. regulator banned drugs from the Indian drug maker's Paonta Sahib, Mohai and Dewas plants, citing violations of its good manufacturing practices.