FDA 483 - Quality Packaging Specialists International, LLC - October 03, 2025

Quality Packaging Specialists International, LLC, located in Burlington, NJ, was inspected by the FDA from September 29 to October 3, 2025. The inspection resulted in an FDA Form 483, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlighting two key observations regarding the firm's laboratory operations and equipment management.

The primary concern noted was deficient laboratory records, specifically the absence of a second-person review for accuracy and completeness on method verification reports. This was observed for critical test methods related to oral solutions, including identification by NMR and HPLC, and impurity limit analyses.

Secondly, the inspection found that routine inspection and qualification of electronic equipment were not performed according to a written program. The firm's Laboratory Information Management System (LIMS), implemented in (b)(4), had not been formally qualified. Furthermore, a Stability/Environmental Chamber designated for stability sample storage lacked complete validation, with the performance qualification (PQ) remaining undone despite earlier installation and operational qualifications. The company is expected to implement corrective actions to address these deficiencies in laboratory record review, data integrity, and equipment validation to ensure regulatory compliance.