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Waste Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality, and purity of drug products Jiangsu Hengrui Pharmaceuticals Co., Ltd |
16 Jan 2024 | Normal | Justification: The observation relates to the improper handling and security of drug products awaiting destruction, linking to Waste Management. Excerpt: Parenteral drug products awaiting destruction in your waste area are not secure. During our (b) (4) walkthrough on 01/08/2024 we observed doors to your waste building open and no personnel present. View Details |
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