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# Violations Found at 3 Ipca Laboratories India Plants
- URL: https://www.fdaweb.com/violations-found-at-3-ipca-laboratories-india-plants/
- Published: 2016-02-09T12:00:00.000Z
- Updated: 2026-09-15T02:34:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134705

> A 2014 FDA inspection at Ipca Laboratories’ Ratlam, Pithampur, and Piparia Silvassa facilities in India found significant violations for finished pharmaceuticals and active pharmaceutical ingredients, including “systematic data manipulation,” according to a 1/29 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484910.htm?ref=fdaweb.com). Violations included:  
>  
>  
> **Ratlam Facility**  
> failing to have computerized systems with sufficient controls to prevent unauthorized access or changes to data; failing to adequately investigate and resolve critical deviations; and failing to follow and document laboratory controls at the of performance and failing to document and explain any departures from laboratory procedures.  
>  
>  
> **Pithampur Facility**  
> failing to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards.  
>  
> **Piparia Silvassa Facility**  
> failing to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards; and failing to have laboratory controls establish scientifically sound test procedures to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.  
>  
> “Our investigators observed systematic data manipulation and other current good manufacturing practice violations and deviations at three separate sites,” the letter says. “Your quality system does not adequately ensure the accuracy and integrity of the data generated and available at your facilities to support the safety, effectiveness, and quality of your drugs.”  
>  
> The company was told to respond with a list of specific steps taken to correct and prevent the recurrence of violations and deviations and a timetable for completing the actions.