FDA EIR - Vista Organics Pvt. Ltd. - July 12, 2016

This report details an FDA inspection of Vista Organics Pvt. Ltd., a foreign manufacturer of bulk dietary supplement ingredients located in Bhopal, Madhya Pradesh, India. The inspection, the firm's initial one by the FDA, was conducted from July 8 to July 12, 2016. It was performed under the regulatory framework of Compliance Guidance Program Manuals 7321.008 (Dietary Supplements - Import And Domestic) and 7303.803 (Domestic Food Safety Program), focusing on adherence to the Food, Drug, and Cosmetic Act for products intended for export to the United States. The scope of the inspection covered various aspects of the firm's operations, including the manufacturing of Zinc Picolinate, the physical condition of the plant and equipment, raw material and finished product storage, employee training, recall procedures, and consumer complaint processes. Records related to sanitation and microbiological testing were also reviewed. Significantly, the inspection concluded without the issuance of an FDA Form 483, Inspectional Observations. No objectionable conditions were noted, and no warnings, recommendations, or suggestions were provided to the firm's management. The report indicates no main violations or issues were identified, and therefore, no specific required actions were mandated as a result of this inspection. The firm maintained accurate food facility registration and no samples were collected.