FDA 483 - B & J Group - October 02, 2023

The FDA inspected B & J Group in Morrisville, PA, a manufacturer of OTC veterinary drug products, from September 26 to October 2, 2023. The inspection revealed six significant deficiencies, including a lack of a stability testing program, inadequate component identification, uncalibrated laboratory instruments, and poor record-keeping for retain samples, cleaning logs, and batch production. Several of these issues were noted as repeat observations, indicating persistent non-compliance.