# FDA 483 - Tens Plus Industrial Co. - November 21, 2024

Source: https://www.keypedia.com/records/483/tens-plus-industrial-co/a190db17-4e45-4e0e-958f-a2aa258a69ad

> FDA 483 for Tens Plus Industrial Co. on November 21, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tens Plus Industrial Co.
- Inspection Date: 2024-11-21
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: Tens Plus Industrial Co., a medical device manufacturer in Kwun Tong, Hong Kong SAR, was cited for multiple significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for design control, complaint handling, process control, supplier management, labeling, and medical device reporting. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

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

Company: https://www.keypedia.com/companies/tens-plus-industrial-co/e1c968db-87d5-41a3-9f4e-edf7c2752eb0

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