# FDA 483 - Hybio Pharmaceutical Co. Ltd (Site 1) - Unknown Date

Source: https://www.keypedia.com/records/483/hybio-pharmaceutical-co-ltd-site-1/b007a6a1-03fa-49f9-ae16-196878373dfe

> FDA 483 for Hybio Pharmaceutical Co. Ltd (Site 1) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hybio Pharmaceutical Co. Ltd (Site 1)
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Hybio Pharmaceuticals Co. Ltd. in Shenzhen, China, an API manufacturer, was cited for significant deficiencies across its manufacturing operations. Observations included unvalidated in-process analytical methods and inadequate protective apparel practices by operators, leading to potential product contamination. Additionally, poor air handling system configuration and deficient equipment cleaning procedures for laminar flow hoods were noted, both posing cross-contamination risks.

## Related Documents

- [EIR - 2015-06-26](https://www.keypedia.com/records/eir/hybio-pharmaceutical-co-ltd-site-1/76a71a07-5714-4010-baea-74791d10776b)

## Related Officers

- [Dennis Cantellops Paite](https://www.keypedia.com/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)

Company: https://www.keypedia.com/companies/hybio-pharmaceutical-co-ltd-site-1/b4b99c5d-801d-40aa-8885-30d1ddfedfad

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