# FDA 483 - Hybio Pharmaceutical Co. Ltd (Site 1) - June 26, 2015

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 June 26, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hybio Pharmaceutical Co. Ltd (Site 1)
- Inspection Date: 2015-06-26
- 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)
- [EIR - 2018-03-30](https://www.keypedia.com/records/eir/hybio-pharmaceutical-co-ltd-site-1/372a5947-486f-439d-8e42-5e8561b837ef)

## Related Officers

- [Dennis Cantellops, Consumer Safety Officer](https://www.keypedia.com/people/dennis-cantellops-consumer-safety-officer/797d73b0-7565-4613-9bc0-806091c80008)

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