Shandong Lukang Shelile Pharmaceutical Co., Ltd.May 30, 2025

FDA 483 - Shandong Lukang Shelile Pharmaceutical Co., Ltd. - May 30, 2025

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Shandong Lukang Sheile Pharmaceutical Co., Ltd. in Zoucheng, China, received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's handling of Out-of-Specification (OOS) results, including inadequate investigations and unjustified root causes. Additionally, the Quality Unit's procedures for retain sample management were not adequately defined or followed.

Company: Shandong Lukang Shelile Pharmaceutical Co., Ltd.
Inspection Date: May 30, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Rajiv R. Srivastava (Consumer Safety Officer)

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