# FDA 483 - Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) - August 08, 2023

Source: https://www.keypedia.com/records/483/hybio-pharmaceutical-co-ltd-pingshan-factory/33e97dae-850f-44fe-ae93-7066ca281f55

> FDA 483 for Hybio Pharmaceutical Co., Ltd. (Pingshan Factory) on August 08, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hybio Pharmaceutical Co., Ltd. (Pingshan Factory)
- Inspection Date: 2023-08-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hybio Pharmaceutical Co., Ltd.'s Pingshan Factory, a sterile drug manufacturer, revealed significant deficiencies in aseptic processing and equipment cleaning. Observations included inadequate sterility testing, poor aseptic techniques by operators, and improper storage of tools, leading to potential microbiological contamination. Additionally, the firm lacked specific written procedures for cleaning and sanitizing critical equipment components within the aseptic processing area.

## Related Officers

- [Jusho Pak](https://www.keypedia.com/people/jusho-pak/ab98135a-9816-4c8e-bd9b-fb331a5f353e)
- [Amy Chua](https://www.keypedia.com/people/amy-chua/e00264b7-f9e6-40f1-9a83-32ee7af08139)

Company: https://www.keypedia.com/companies/hybio-pharmaceutical-co-ltd-pingshan-factory/a9645470-bf0e-4ade-9133-9705219e306f

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