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Asset Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| The equipment used in the manufacturing of intermediates is not properly maintained for its intended use. Xinxiang Tuoxin Pharmaceutical Co., Ltd. |
22 Oct 2021 | Normal | Justification: Asset management is crucial for ensuring equipment performance remains within specified requirements to prevent product contamination. Excerpt: The (b) (4) equipment (ID: 07FS-001) located in Workshop used in the manufacturing of the intermediate was observed to be damaged. View Details |
| You did not install a (b) (4) capable of (b) (4) when (b) (4) (b)(4) is used at a product filling machine. Abbott Nutrition |
15 Oct 2021 | Normal | Justification: The observation centers around equipment installation, falling squarely under Asset Management, which deals with equipment adequacy and installation. Excerpt: on Filler Lines (b) (4), , the finished product is (b) (4) . View Details |
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