FDA 483 - Innogenix, LLC. - November 15, 2024

Innogenix, LLC. received an FDA Form 483 following an inspection conducted from November 6 to November 15, 2024. The inspection revealed several significant observations indicating non-compliance with regulatory standards, primarily related to Current Good Manufacturing Practices (cGMP) and the Drug Supply Chain Security Act (DSCSA).

Key issues identified included inadequate controls over computer systems and data integrity. Specifically, the firm's IR Spectrophotometer software allowed data deletion and lacked user access controls, and electronic audit trail reviews for various lab instruments were either not performed or were deficient. Production and process control procedures were found to be inadequate, with unapproved equipment changes, a lack of periodic camera challenges for packaging line verification, and incomplete Quality Assurance review of equipment qualification studies.

Furthermore, the FDA observed failures in establishing and following written procedures for equipment cleaning and maintenance. This included a lack of scientific basis for equipment clean hold times, deficiencies in cleaning validation studies, and an absence of established dirty hold times, leading to observations of soiled equipment. Data backup procedures were also found to be insufficient, lacking requirements for periodic restoration testing. Finally, Innogenix, LLC. lacked essential written procedures to ensure compliance with DSCSA verification requirements, such as responding to FDA requests, investigating suspect products, and record-keeping. The company must now address these observations to ensure adherence to federal regulations and product quality and safety.