FDA 483 - Ion Labs Inc. - April 28, 2023

During an inspection conducted from April 24 to April 28, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Ion Labs Inc., a drug manufacturer and repacker located in Largo, FL. This document outlined significant observations indicating deviations from current Good Manufacturing Practices (cGMP) regulations.

Key issues identified included deficiencies in the Facilities and Equipment System, specifically that a blister pack machine used for packaging tablets lacked proper equipment qualification, process validation, and cleaning validation. The Quality System was cited for failing to ensure the quality control unit's full responsibility in approving and rejecting procedures, as well as for inadequate electronic record-keeping practices. This included untracked analytical forms, incomplete scanned cleaning logs, absence of equipment use logbooks, lack of review for electronic data with disabled audit trails, and the failure to perform annual product reviews for certain tablets from 2020 to 2022. Furthermore, the Laboratory System demonstrated weaknesses, such as not conducting growth promotion for in-house media and lacking traceability for media lots. Lastly, the company failed to maintain written records of investigations into unexplained discrepancies, including an incomplete investigation into a production inspection check recording failure.

These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, require Ion Labs Inc. to implement comprehensive corrective and preventive actions to ensure compliance with regulatory standards for drug product manufacturing, quality, and record integrity.