# FDA 483 - YAHON ENTERPRISE CO., LTD - December 21, 2023

Source: https://www.keypedia.com/records/483/yahon-enterprise-co-ltd/c1a06efb-7a07-4221-80e1-5b8d5c5ec1cc

> FDA 483 for YAHON ENTERPRISE CO., LTD on December 21, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: YAHON ENTERPRISE CO., LTD
- Inspection Date: 2023-12-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Yahon Enterprise Co., Ltd. in Trang Bom District, Vietnam, was cited for numerous significant deficiencies during an FDA inspection related to drug product manufacturing. The firm failed to ensure product quality and integrity through inadequate testing, lack of validation, poor record-keeping, and insufficient quality control procedures. These issues indicate a systemic failure to adhere to Good Manufacturing Practices for drug products intended for the U.S. market.

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.keypedia.com/companies/yahon-enterprise-co-ltd/e294bf2b-a876-48b0-b4c5-aa3393d57ce2

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