10. November 2020
This Warning Letter issued by the FDA on 29 January 2016 to the Indian manufacturer Ipca Laboratories Limited in India (with 3 production sites for APIs and medicinal products) is based on 3 FDA inspections performed in July 2014, in October 2014 and in December 2014.
For example, the inspectors complained about the missing controls of computerised systems. Laboratory employees were able to manipulate the process parameters of chromatographic analyses to obtain appropriate results.
Concretely, it has been noticed by the review of the 12-month commercial stability assay test for residual solvent by GC (Gas Chromatography). Here, the original peak hasn't been integrated correctly. Standards and samples had been processed with different integration parameters without any written justification. As the inspector asked for reprocessing the chromatograph with the correct integration parameters, an OOS result was obtained which didn't comply with the specifications for this stability testing.
Moreover, the logbook data have been modified later through manipulation. The FDA inspection also showed that during the review of the GC audit trails some injections have been completely deleted without any justification.
The same findings were made with regard to HPLC analyses. Here again, the review of the HPLC audit trail showed that data had been deleted without any justification.
In its answers to the FDA, the company concentrated only on the printed-out data but not on the original electronic raw data.
In summary, this Warning Letter criticises that the critical deviations haven't been found by the own longstanding investigations of the company. Although they had only limited time, the FDA inspector discovered manipulations of data including deleted injections, re-injections and missing injections.
According to this Warning Letter, there have been again major concerns regarding the authenticity and reliability of data produced in this company. A comprehensive CAPA plan has been requested by the FDA within 15 working days of receipt of this letter.
To get more details please see the complete Ipca Laboratories Limited FDA Warning Letter.
Source: FDA, USA