InvaGen Pharmaceuticals, Inc. – FDA 483, May 26, 2015

This FDA Form 483 document details observations made during an inspection of InvaGen Pharmaceuticals, Inc., a pharmaceutical manufacturer located at 7 Oser Ave, Hauppauge, NY. The inspection occurred on May 13, 14, 15, 19, 22, and 26, 2015.

The primary observation (Observation 1) notes that the responsibilities and procedures of the quality control unit are not fully followed. Specifically:

1. **CAPA System Deficiencies:** The firm's Corrective And Preventive Action (CAPA) system (SOP# QA036) is not routinely employed as described. Only eight CAPAs were initiated between October 26, 2010, and November 12, 2013. Corrective actions for prior FDA inspection observations were handled via change control instead of the CAPA system, which is intended to track and evaluate the adequacy of corrective actions. Examples include failure to initiate CAPAs to evaluate the effectiveness of retraining for analyst errors (10 Laboratory Failure Reports, 56 Laboratory Deviation Notices in 2014) and failure to evaluate root causes and corrective actions for 90 Laboratory Deviation Notices in 2014 that led to retesting.

2. **Unresolved Product Discoloration:** The firm has not determined the root cause or extent of discoloration for Hydroxyzine HCl