Has GMP Inspection Report of Slovenian GMP Inspectors caused FDA and Health Canada Import Alerts?

Recommendation

4/5 February 2020
Prague, Czech Republic

Handling of Foreign Particles in APIs and Excipients

In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. The Inspectors found 17 GMP deviations of which 5 were rated major. The combination of theses major deviations represents a critical deficiency leading to a potential risk for patients. This has caused a GMP Non-Compliance Report in EudraGMDP and the suspension of all CEPs of the company. The Inspectors have requested the marketing authorisation holders using APIs from Polydrug Laboratories to change their API supplier. Please read our GMP News about the GMP Inspection at Polydrug for more details.

Now it seems that both Health Canada and the US FDA have used the GMP inspection report of the Slovenian Authority to decide on consequences for supplies to Canada and the US. Already in June Health Canada have issued a press release in which they requested Canadian importers to voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Polydrug Laboratories, in Ambarnath, Maharashtra, India, due to data integrity concerns.

Now also FDA has issued an Import Alert. Products manufactured by Polydrug can no longer enter the US market due to serious GMP violations. There is no concrete evidance that the EU Inspections by the Slovenian Authority is the only reason for the actions by Health Canada and US FDA. But it is very likely that the EU Inspection has been the initial trigger for actions taken by Canada and US.