483
Shandong Lukang Shelile Pharmaceutical Co., Ltd.Shandong Lukang Shelile Pharmaceutical Co., Ltd. – FDA 483, May 30, 2025
Record Details
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.
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ID · 17306efb-0e2e-4e3f-a743-d6cc407ded69
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