# FDA 483 - Forcemech International LLC - March 17, 2020

Source: https://www.keypedia.com/records/483/forcemech-international-llc/47e49ed8-f041-4887-84b3-41c5e64f32ed

> FDA 483 for Forcemech International LLC on March 17, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Forcemech International LLC
- Inspection Date: 2020-03-17
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Forcemech International LLC, a repacker/relabeler of Class 2 power wheelchairs in Pearland, TX, revealed significant deficiencies across its quality system. The firm failed to adequately handle and investigate complaints, including major safety issues like wheelchair frames snapping and controller malfunctions. Additionally, the company lacked established procedures for incoming product acceptance, supplier evaluation, service report documentation, distribution records, and a fully implemented quality system.

## Related Documents

- [483 - 2021-04-16](https://www.keypedia.com/records/483/forcemech-international-llc/d4c70c2c-df53-4f62-bc63-b16b8a37a8b0)
- [WARNING_LETTER - 2022-04-04](https://www.keypedia.com/records/warning_letter/forcemech-international-llc/bf609d37-e336-4ae1-89fd-3ba58f4ebff7)
- [483 - 2023-04-06](https://www.keypedia.com/records/483/forcemech-international-llc/cbad169b-d8b7-4ab4-890c-7b1736b946f9)

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/forcemech-international-llc/4e22e86e-30dc-4412-9a9b-62e2361bbf4f

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9