In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate.
During an inspection at the API maker’s Boisar, Maharashtra facility, inspectors allegedly uncovered 24 deficiencies, revealing problems with general finishing steps, manufacturing procedures and “the quality system of the company as a whole,” according to the agency.
The agency supposedly found one critical deficiency, which was Anuh’s failure to identify the original manufacturers of active ingredients to its customers.
For example, a number of active substances appeared to be micronized from other sources, including one that was a noncompliant source based in China. Substances made at other sites supposedly were exported to Europe under the Anuh name.
The agency chastised the company for this “severe lack of transparency” regarding its manufacturing activities, particularly because there was no proof that all active substances were manufactured at the company’s Boisar site.
Two major deficiencies also were alleged, including issues with documentation management. Investigators highlighted the discovery of several documents “within a pile of rubble,” on the side of a wall.
FDA investigators also said they found the company’s process validation system wanting, maintaining that no validation data were available for the blending of the processed batches and cleaning of the air jet mill used for micronization.
Keep pace with the latest worldwide inspections news by subscribing to FDAnews’ Inspection Insider. Nowhere else will you find a more comprehensive collection of inspections intelligence. With Inspection Insider, you’ll have an unmatched source of critical information to ensure you’re prepared when investigators come knocking.