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Zachary Brennan
11-Mar-2015
For the second time this year, the FDA has issued a warning letterFor example, your firm could not provide electronic raw data supporting your High Pressure Liquid Chromatography (HPLC) testing in your Validation Reportinadequate controls over access to your data raise questions about the authenticity and reliability of your data and the quality of the APIs you produceAcetyl Salicylic Acid plant in Bangpoo was inspected by the US FDA in April 2014requires additional stronger actions to be taken onNovacyl is fully mobilized to diligently address the US FDA requests in the coming weeks with the support of a dedicated team of internal and external recognized CGMP experts. We are confident in our capacity to implement a suitable action plan in due time without discontinuing our current sales activitiesan in-depth review and evaluation of your reprocessing procedures, and an evaluation of all products made with reprocessed material within expiryWuxi, China-based siteobserved similar data integrity concerns