Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer

During its inspections, the FDA has been observing insufficient data integrity quite often in the Far East. Now, European production sites are not always exemplary. A Warning Letter recently published for the Czech Company Interpharm Praha describes considerable deficiencies in the area of quality control with regard to API and finished products testing.

Basically, the personnel of the analytical laboratory had full access to the data processing of the HPLC- system. Accordingly, the possibility to delete data, to integrate peak areas "by hand" and to eliminate or add samples from sequences was used extensively. These manipulations were visibly clear in the audit trail: among the round 9,000 entries, more than 5,000 actions were traced as data deletion, manual integration of peaks, etc. At the FDA inspectors' request, the employees of the laboratory indicated that such actions are common.

One of the reasons why data had been beautified in such a way is also due to the fact the chromatographic system was not able to execute correct integration of peak areas. The FDA inspector identified partly incomplete or missing integrations of peaks and concluded that the system was wholly inadequate for the purpose. Batch release decisions were thus based on incomplete data, which is a grave GMP-deficiency.

At the end of the Warning Letter, a list of measures is included for the company to fulfil if it still wants to distribute its products on the US American market.

For further details please see the FDA's Warning Letter issued to Interpharm Praha.