FDA EIR - A+ Secure Packaging LLC - August 16, 2017

An FDA inspection of A+ Secure Packaging LLC, a human drug repackager and relabeler, was conducted from August 14-16, 2017. This surveillance Good Manufacturing Practices (GMP) inspection, under compliance programs for drug repackagers, found no issues warranting an FDA-483. However, the inspection highlighted two key areas for improvement. Firstly, a risk of cross-contamination was identified due to the repackaging of Spirulina Plantesis Egg Mix, a high-alert allergen, followed by other products without additional cleaning procedures. Secondly, Quality Assurance approved products were inappropriately stored in the incoming Quarantine area. Management promptly committed to correcting both issues, immediately rectifying the storage concern. Additionally, the report noted an ongoing recall, initiated in November 2016, for Losartan Potassium 50mg Tablets due to a mix-up where cartons were incorrectly labeled as Metoprolol Succinate. The company is registered with FDA as a human drug and medical device repackager/relabeler, underscoring the importance of rigorous quality controls.