FDA Issues Warning Letter to Ipca LaboratoriesBy
The US Food and Drug Administration (FDA) has posted a Warning Letter to Ipca Laboratories for violations of current good manufacturing practices (cGMP) based on inspections of three facilities of the company in India made in 2014 for data integrity issues. The violations were noted at the company’s active pharmaceutical ingredient (API) manufacturing facility in Ratlam, Madhya Pradesh based on a inspection conducted July 14-18, 2014 and at two manufacturing facilities for finished pharmaceuticals in Pithampur, Madhya Pradesh based on an inspection in October 13-17, 2014 and at facility in Piparia Silvassa Union Territory of Dadra & Nagar Haveli based on an inspection made December 1-19, 2014. The FDA reviewed the firm's responses of August 8 and November 7, 2014, and January 9, 2015 with respect to these facilities.
The FDA said that it observed systemic data manipulation and other cGMP violations and deviations at the three sites. It said that the company’s quality system does not adequately ensure the accuracy and integrity of the data generated and available at its facilities to support the safety, effectiveness, and quality of your drugs. The FDA is requesting the following from the company:
â€¢ A comprehensive investigation and evaluation, including a description of methodology. Results should include conclusions about the extent of data integrity deficiencies and their root causes, which may involve record control, contemporaneous recording, deletion of data, and other data integrity deficiencies.
â€¢ A risk assessment of how the observed deficiencies may affect the reliability and completeness of quality information available for the company’s drugs and a determination of the consequences of deficient documentation practices on the quality of drugs released for distribution.
â€¢ A management strategy that includes a detailed global corrective action and preventive action plan. The agency is requesting the company include the actions it will take, such as contacting customers, recalling drugs, conducting additional testing and/or adding lots to your stability programs, or other steps to assure the quality of the drugs manufactured under the deficient conditions noted in the inspections. The agency is also asking the company to indicate measures it will take, such as revising procedures, implementing new controls, training or re-training personnel, or other actions to prevent the recurrence of cGMP deviations, including breaches of data integrity.