FDA 483 - Jbc Corp - May 24, 2019

Jbc Corp, a drug repacker in Virginia Beach, VA, was cited with five observations during an FDA inspection from May 20-24, 2019. The inspection revealed significant deficiencies in quality control unit procedures, environmental controls, batch record documentation, employee training, and complaint handling, indicating a lack of fundamental GMP compliance. These issues raise concerns about the identity, strength, quality, and purity of drug products assembled into medical kits.