FDA 483 - BAPS Swaminarayan Herbal Care, A Unit of Divine Energy - August 17, 2019

The FDA inspected BAPS Swaminarayan Herbal Care, a manufacturer of OTC drug products, and found significant deficiencies. The firm lacked written procedures for quality control, supplier qualification, process and equipment validation, and material sampling. Additionally, issues were noted with personnel training, laboratory controls, batch record documentation, and annual product reviews, indicating a broad failure to adhere to cGMP requirements.