FDA EIR - AvKARE - November 02, 2022

An FDA compliance follow-up inspection of AVKARE LLC, an own label distributor of repackaged human generic prescription drugs in Pulaski, TN, was conducted from October 31 to November 2, 2022. The inspection, carried out under current Good Manufacturing Practices (cGMP) guidelines (CPGM 7356.002), aimed to assess the facility's compliance. AVKARE LLC primarily functions as an office headquarters and retain sample storage, with all drug operations outsourced to contract parties; it does not perform manufacturing, repackaging, or relabeling onsite.

The inspection resulted in a "Voluntary Action Indicated" (VAI) classification and a 1-item FDA Form 483. The main violations, citing 21 CFR 211.22(d), centered on the firm's quality unit. Firstly, AVKARE LLC failed to establish written procedures for label investigations. This was evidenced by a recall of Lamotrigine Tablets where incorrect dosage information was present on the label, and no formal investigation procedure was available. Secondly, the quality unit lacked document-controlled procedures for reviewing batch records; an employee was observed using uncontrolled personal notes during this critical process.

Discussions also highlighted an unclear quality agreement with a contract manufacturer regarding AvKARE’s responsibilities and a lack of detailed execution steps in quarantine and vendor authentication procedures. Management acknowledged these issues and committed to providing a written response within fifteen business days, indicating forthcoming corrective actions.