# FDA 483 - Kyongbo Pharmaceutical Co., Ltd. - December 02, 2019

Source: https://www.globalkeysolutions.net/records/483/kyongbo-pharmaceutical-co-ltd/724a8112-263e-48b8-b476-8814f8a16da8

> FDA 483 for Kyongbo Pharmaceutical Co., Ltd. on December 02, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kyongbo Pharmaceutical Co., Ltd.
- Inspection Date: 2019-12-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Kyongbo Pharmaceutical Co., Ltd. in Asan-Si, Korea, an API manufacturer, was inspected from December 2-6, 2019. The inspection revealed significant deficiencies in laboratory controls, specifically concerning data integrity and security for analytical instruments and microbiology laboratory records. These issues indicate a lack of proper controls to ensure data is fully secured and attributable.

## Related Officers

- [Stephanie A. Slater](https://www.globalkeysolutions.net/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

Company: https://www.globalkeysolutions.net/companies/kyongbo-pharmaceutical-co-ltd/6b8fd90f-4fa3-4c7b-9ed6-a8a8f4b511da

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