Most recently the use of ‘integration interruption’ capability of chromatography data systems has been identified as a means of data manipulation. In addition, some firms have gone to extremes in physically blocking the FDA’s access to areas which they have a right to inspect.
Polydrug Fails In EDQM Inspection
Polydrug Laboratories receives FDA Warning letter
Polydrug Laboratories Pvt. Ltd. on FDA Import Alert List
Health Canada requests quarantine of drugs linked to Polydrug Laboratories due to data integrity concerns
Slovenian regulators slam Polydrug API plant in India
India`s Polydrug Labs fails EDQM inspection