# Ami Organics Limited – FDA 483, Mar 13, 2020

Source: https://www.keypedia.com/records/483/ami-organics-limited/6880775c-8925-4456-8fba-796ad2522da0

> FDA 483 for Ami Organics Limited on March 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ami Organics Limited
- Inspection Date: 2020-03-13
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Ami Organics Pvt. Ltd. in Surat, India, an API intermediates manufacturer, revealed significant deficiencies in data integrity and record management. Observations included failures to retain manufacturing records, validate analytical methods, control computerized systems, and ensure accurate laboratory calculations. These issues indicate a lack of robust quality control and data governance practices.

## Related Officers

- [Jose Hernandez-Guzman](https://www.keypedia.com/people/jose-hernandez-guzman/5e522aa9-a613-408f-b360-74c0fe4d8b30)

Company: https://www.keypedia.com/companies/ami-organics-limited/d75b82c8-ba48-45d1-a55f-c8cdcadcf9e0

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4