FDA EIR - Unknown Company - November 03, 2017

A routine Good Manufacturing Practices (GMP) inspection of Nuray Chemicals Private Limited, an active pharmaceutical ingredient manufacturer, was conducted by the FDA from October 31 to November 3, 2017. The inspection, which covered the firm's Quality System, Facilities and Equipment, Materials System, Production, Packaging and Labeling, and Laboratory System, did not result in an FDA Form 483, Inspectional Observations. However, several areas requiring attention were identified and discussed with company management. Key issues included the need for end-of-use integrity testing of microbiological filters on critical systems, and an observed failure to notify Quality Assurance or Purchasing about raw materials not meeting established acceptance standards, contrary to standard operating procedures. Furthermore, the validation for the firm's water systems alarms appeared incomplete, with protocols lacking clear directions for acceptance testing and proper documentation of results. There was also an absence of written conclusions for some validation exercises. While no formal regulatory actions were mandated, Nuray Chemicals Private Limited's management acknowledged these observations and committed to implementing corrective actions. Documentation supporting initial corrective measures was provided, and the firm assured the FDA that further steps would be taken to address all identified practices and situations. The inspection was classified as "No Action Indicated," with routine surveillance planned as a follow-up.