# Shandong Anhong Pharmaceutical Co., Ltd. – FDA 483, Jun 26, 2026

Source: https://www.keypedia.com/records/483/shandong-anhong-pharmaceutical-co-ltd/f5496f60-3dfc-46fe-aab5-0905d76562a6

> FDA 483 for Shandong Anhong Pharmaceutical Co., Ltd. on June 26, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shandong Anhong Pharmaceutical Co., Ltd.
- Inspection Date: 2026-06-26
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: An FDA inspection of Shandong Anhong Pharmaceutical Co., Ltd., a sterile and non-sterile API manufacturer, revealed significant deficiencies across multiple quality systems. Observations included inadequate measures to prevent cross-contamination, insufficient investigation of microbial excursions, and poorly developed or followed aseptic procedures. Additionally, the firm failed to validate critical water systems and equipment reuse, and maintained an older QC building in a poor state of repair.

## Related Documents

- [483 - 2020-10-30](https://www.keypedia.com/records/483/shandong-anhong-pharmaceutical-co-ltd/9f201cbb-010b-412d-b8a8-04838f3940ff) — date: October 30, 2020

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/shandong-anhong-pharmaceutical-co-ltd/3b784225-cf8c-4bc5-a5ad-b5e47f484f59

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe