The Indian active pharmaceutical ingredient (API) maker had its Maharashtra, Mumbai facility inspected in March 2015 and earlier this month it received a Warning Letter from the US Food and Drug Administration (FDA) identifying several significant deviations from current good manufacturing practice (cGMP).
Among the issues cited, the Agency said Polydrug failed to record and investigate all quality-related customer complaints reporting “API that were either sub-potent or contained filth,” including products allegedly containing particles and hairs, an insect and dirt, and having a low assay value.
“Your firm’s poor complaint handling practices and your inability to prevent and detect product quality defects, such as filth, indicate significant lapses in your firm’s quality system,” the FDA wrote in the letter dated April 14.
“You are responsible for ensuring that prior to release your API meet quality and safety requirements and for assuring that any subsequent quality defects are thoroughly investigated. You are also responsible for taking appropriate corrective actions and preventive actions.”
The Agency also picked up on the firm’s failure to review and investigate all production deviations, with one investigator finding a torn page from a batch production record for a lot of API “in the trash.”
And - in the latest example of an Indian manufacturer being slammed with data integrity issues - the FDA also highlighted Polydrug’s failure in ensuring its computerised systems have sufficient controls to prevent unauthorised access or changes to data.
Earlier this month the FDA published draft guidance looking to stem what it described as the “major problem” of data integrity.
The Warning Letter is the latest regulatory rap for Polydrug.
In June 2015, Slovenian regulators logged 17 observations of breaches of cGMP at the plant on the EU’s Eudra GMP database, leading to the suspension of certificates of suitability for seven APIs made at the Polydrug site.
Later that month, Health Canada called for the quarantine of Polydrug APIs over concerns about its manufacturing plant.
And in September, the FDA issued an import alert against the API maker barring the export of ingredients made at the Mumbai site to the US.