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

Source: https://www.keypedia.com/records/483/shandong-lukang-shelile-pharmaceutical-co-ltd/17306efb-0e2e-4e3f-a743-d6cc407ded69

> FDA 483 for Shandong Lukang Shelile Pharmaceutical Co., Ltd. on May 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shandong Lukang Shelile Pharmaceutical Co., Ltd.
- Inspection Date: 2025-05-30
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/shandong-lukang-shelile-pharmaceutical-co-ltd/951ce05d-eb54-4085-9e1c-8fe979d9f0bb

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