# FDA 483 - Challenge Bioproducts Company, Ltd. - October 31, 2022

Source: https://www.keypedia.com/records/483/challenge-bioproducts-company-ltd/d4726559-948d-4fba-93fb-052ba7234c1d

> FDA 483 for Challenge Bioproducts Company, Ltd. on October 31, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Challenge Bioproducts Company, Ltd.
- Inspection Date: 2022-10-31
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Challenge Bioproducts Company, Ltd. in Tou-Liu City, Taiwan, received a Form 483 citing significant deficiencies in quality assurance, facility and equipment cleaning, and in-process sampling. Issues included inadequate deviation investigations, unverified analytical methods, lack of cleaning validation, and unsanitary sampling practices. These observations indicate a high risk of product adulteration and lack of control over manufacturing processes.

## Related Officers

- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.keypedia.com/companies/challenge-bioproducts-company-ltd/cf169417-15dd-4cf2-b572-c484799bb893

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd