# FDA 483 - Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd. - September 19, 2024

Source: https://www.keypedia.com/records/483/dongguan-aidisy-machinery-electronic-equipment-co-ltd/f404efb8-f67f-4537-b2b5-a62fdfbbfb3e

> FDA 483 for Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd. on September 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd.
- Inspection Date: 2024-09-19
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd. in Dongguan, China, a medical device manufacturer, revealed multiple significant deficiencies in its quality system. The firm failed to establish adequate procedures for design control, complaint handling, finished device acceptance, in-process product control, and labeling activities. Additionally, sampling plans for functional tests were not based on valid statistical rationale, indicating a broad lack of robust quality management practices.

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/dongguan-aidisy-machinery-electronic-equipment-co-ltd/d512fb42-8e41-43c0-9978-8b4bbc6875f5

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