# FDA 483 - Sartorius Korea Biotech Co., LLC. - May 20, 2022

Source: https://www.globalkeysolutions.net/records/483/sartorius-korea-biotech-co-llc/7896edc9-3727-4e18-8846-a07be8b6eb57

> FDA 483 for Sartorius Korea Biotech Co., LLC. on May 20, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sartorius Korea Biotech Co., LLC.
- Inspection Date: 2022-05-20
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sartorius Korea Biotech Company Limited, a testing laboratory in Seongnam-Si, Gyeonggi-do, was cited for significant deficiencies in its quality system. Observations include inadequate deviation investigations, lack of detailed written procedures for laboratory operations and contamination control, deficient laboratory record-keeping, and insufficient equipment qualification and employee training. These issues indicate a lack of robust controls to assure product quality and purity.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/sartorius-korea-biotech-co-llc/f1a27946-994f-4bd2-a449-167df6a86e04

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