# FDA 483 - Qilu Animal Health Products Co., Ltd. - April 11, 2025

Source: https://www.globalkeysolutions.net/records/483/qilu-animal-health-products-co-ltd/bb35422d-7a38-4adb-a049-5d2ecea1d3cb

> FDA 483 for Qilu Animal Health Products Co., Ltd. on April 11, 2025. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Animal Health Products Co., Ltd.
- Inspection Date: 2025-04-11
- Product Type: veterinary
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Qilu Animal Health Products Co., Ltd. in Jinan, China, a sterile veterinary drug manufacturer, revealed significant deficiencies in sterility assurance. Observations included inadequate laboratory testing for sterility and pyrogen-free requirements for drug product batches, and insufficient validation of sterilization processes to prevent microbiological contamination. These issues indicate a high risk of product contamination and non-compliance with sterile manufacturing standards.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/qilu-animal-health-products-co-ltd/8466eb41-9765-42fd-bcb9-1967ddab39db

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8