The USFDA has issued a warning letter against Mumbai-based Polydrug Laboratories for violation of current good manufacturing practice (CGMP) in the manufacturing of active pharmaceutical ingredients (API).
Citing a number of issues, including quality control, the US health regulator said it "may withhold approval of any new applications or supplements listing your firm as drug manufacturer" till corrections were made by the company which has been placed on import alert on September 11, 2015.
"We identified significant deviations from CGMP for the manufacture of API. These deviations cause your drugs to be adulterated...," the USFDA said in a letter to the company's Managing Director Punit Thakur.
"The method used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP," it added.
The USFDA said Polydrug failed "to record and investigate all quality-related customer complaints according to an established procedure".
Besides, it failed to review and investigate all production deviations as investigators found discrepancies between a discarded page of production record and the complete batch record that the company represented as the official record for that lot, the USFDA added.
The health regulator also pulled up the company for failure of computerised systems to have sufficient controls to prevent unauthorised access or changes to data.
"We strongly recommend that you engage a third-party consultant with appropriate CGMP expertise to assess your firm's facilities, procedures, processes, systems and data integrity to ensure the identity, strength, quality, and purity of the API you manufacture," the USFDA said.
