FDA EIR - Amoli Organics Private Limited - July 20, 2018

This FDA Establishment Inspection Report details a routine Good Manufacturing Practices (cGMP) surveillance inspection of Amoli Organics Pvt Limited, an Active Pharmaceutical Ingredient (API) manufacturer, conducted from July 16 to July 20, 2018. The inspection followed Compliance Program 7356.002F for API process inspections and utilized ICH Q7 guidelines for Good Manufacturing Practices. The primary objective was to assess Quality, Production, Packaging and Labeling Systems, and to verify the correction of deficiencies from a previous inspection (March 27-31, 2017).

The prior inspection had identified three main issues: inadequate validation of device software, improper storage conditions for drug products affecting their identity and purity, and a failure to follow written sanitation procedures. The current inspection confirmed that Amoli Organics had successfully corrected these previously cited violations.

Significantly, the 2018 inspection concluded with no new objectionable observations, and therefore, no Form FDA-483 was issued. As a result, the inspection was classified as "No Action Indicated" (NAI), indicating that no further regulatory actions or required actions were necessary based on this assessment. The report was subsequently referred to CDER for review.