FDA EIR - Quality Packaging Specialists International, LLC - November 03, 2017

A routine FDA surveillance inspection of Quality Packaging Specialists International, LLC (QPSI) was conducted from November 1 to November 3, 2017. The inspection, focusing on the company's drug repacking and relabeling operations, also considered their activities in food and medical device packaging, in accordance with CP 7356.002B. While no formal FDA Form 483 (Inspectional Observations) was issued, the FDA investigator identified five significant issues verbally discussed with management at the close-out meeting.

The primary concerns revolved around deficiencies in QPSI's quality system and document control. Specifically, the company was found to have altered Acceptable Quality Limit (AQL) criteria for confirmation verification without proper change control or planned deviation approval, circumventing established procedures. Furthermore, QPSI inconsistently applied its criteria for planned deviations, often misclassifying unplanned occurrences as deviations instead of non-conformances. The quality department's review processes were inadequate, failing to identify and investigate contradictions, date errors, or improper classifications in reports. The document control system also allowed unauthorized edits to controlled documents without necessary approvals or updates to revision numbers and effective dates. Lastly, there was an absence of clear visual indicators in packaging areas to denote the status of the area or the product being processed.

In response, QPSI management committed to several corrective actions, including opening a nonconformance for the AQL issue and initiating a Corrective and Preventive Action (CAPA) to review and enhance related quality and document control procedures. They also pledged to implement visual status indicators in packaging areas. An estimated completion date for these actions was provided for the first quarter of 2018. The inspection confirmed previous voluntary corrections regarding MDR reporting, nonconformance documentation, and DHR labeling requirements.