# FDA 483 - Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.) - January 08, 2024

Source: https://www.globalkeysolutions.net/records/483/amoli-organics-a-division-of-umedica-laboratories-pvt-ltd/a38281dd-dc32-49b6-bbc5-a5ed0ed10ea2

> FDA 483 for Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.) on January 08, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)
- Inspection Date: 2024-01-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.), an Active Pharmaceutical Ingredients Manufacturer in Vadodara, India, identified a significant labeling deficiency. The firm was cited for shipping API products to the US market without including the required Caution Statement and Rx information on their labels. This indicates a failure to comply with specific legal labeling requirements for pharmaceutical ingredients.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.globalkeysolutions.net/companies/amoli-organics-a-division-of-umedica-laboratories-pvt-ltd/b8bc3797-9fd3-4e78-a475-bc53b2f5310e

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1