# FDA 483 - Zhejiang Apeloa Biotechnology Co., Ltd - September 04, 2023

Source: https://www.keypedia.com/records/483/zhejiang-apeloa-biotechnology-co-ltd/e14b1179-310c-41b9-beec-5e2d7f64c32c

> FDA 483 for Zhejiang Apeloa Biotechnology Co., Ltd on September 04, 2023. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Apeloa Biotechnology Co., Ltd
- Inspection Date: 2023-09-04
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Summary: Zhejiang Apeloa Biotechnology Co., Ltd. in Dongyang, China, an animal drug API manufacturer, was cited for significant quality control issues during an FDA inspection. Observations included inadequate investigations into out-of-specification results and contamination, deficient laboratory OOS procedures that could permit retesting without scientific basis, and a water manufacturing system lacking proper validation and maintenance. These findings indicate a need for improved quality management and process control.

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Investigator](https://www.keypedia.com/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.keypedia.com/companies/zhejiang-apeloa-biotechnology-co-ltd/10b6874f-2bf7-417c-88d8-280870d77e7e

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4