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