# FDA 483 - Barox Co., Ltd. - May 18, 2018

Source: https://www.globalkeysolutions.net/records/483/barox-co-ltd/e489929a-b828-47f3-841d-9eb6de4bc8a1

> FDA 483 for Barox Co., Ltd. on May 18, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Barox Co., Ltd.
- Inspection Date: 2018-05-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Barox Co., Ltd., a relabeler of OTC drug products in Seongnam-si, Korea, was cited for significant deficiencies in its quality system. The inspection revealed a pervasive lack of written procedures across critical operations, including quality control, production, labeling, and complaint handling. Additionally, employees, including the Quality Control Unit, were found to lack adequate training in current Good Manufacturing Practices and required procedures, and the firm failed to establish procedures and testing for objectionable microorganisms in its non-sterile drug products.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.globalkeysolutions.net/companies/barox-co-ltd/18571fc5-78e8-4569-a15d-ac91b22c29ca

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