FDA 483 - Mera Pharmaceuticals - June 21, 2019

Mera Pharmaceuticals, a dietary supplement distributor in Kailua Kona, Hawaii, was cited for significant deficiencies in its quality control operations during an FDA inspection. The firm failed to establish and follow written procedures for critical processes such as equipment calibration, quality control responsibilities, supplier qualification, complaint handling, and returned products. Several of these issues were repeat observations from previous inspections, indicating persistent non-compliance.