FDA EIR - Innogenix, LLC. - May 14, 2018

An FDA inspection of Innogenix, LLC was conducted from May 2 to May 14, 2018, under the regulatory framework of a Drug Manufacturing Inspection (CPGM 7356.002) as the firm is a registered pharmaceutical drug manufacturer subject to the FD&C Act. This was an initial inspection, covering Quality, Facilities and Equipment, Material Management, Production, Packaging and Labeling, and Laboratory Control Systems. Notably, no FDA Form 483 (Inspectional Observations) was issued, indicating no formal violations. However, the inspection identified several issues addressed through verbal observations and commitments. The firm had not completed full cleaning validation studies for its equipment, with only verification performed for Acetaminophen and lacking worst-case assessments and maximum allowable carryover calculations for other products. Innogenix committed in writing to conduct cGMP-compliant cleaning validation. Additionally, the procedure for aseptic water sampling was found to be inadequately defined, and laboratory chemists lacked view access to audit trails in their analytical software, which could hinder investigations. These points were discussed verbally with management for corrective action. Furthermore, Pilocarpine HCl tablets failed stability testing, leading the firm to discontinue its development and submission, with no further CAPA initiated. The inspection concluded without formal observations but with a clear understanding of areas for improvement.