# FDA 483 - Scinopharm Taiwan Ltd - April 01, 2022

Source: https://www.globalkeysolutions.net/records/483/scinopharm-taiwan-ltd/e348b126-3a5a-4c4f-9825-24e272cd09d0

> FDA 483 for Scinopharm Taiwan Ltd on April 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scinopharm Taiwan Ltd
- Inspection Date: 2022-04-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: ScinoPharm Taiwan Ltd, a drug substance and sterile drug manufacturer in Shan-Hua, Taiwan, was cited for two observations during an FDA inspection from March 21 to April 1, 2022. The firm failed to follow proper stock rotation for components, leading to out-of-specification drug product, and also failed to re-qualify critical equipment used for sterility assurance and drug product manufacturing. These issues indicate deficiencies in quality control and equipment management.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/scinopharm-taiwan-ltd/fe461fae-c096-4537-985b-2caeeebda3a1

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