# FDA 483 - Forcemech International LLC - April 16, 2021

Source: https://www.keypedia.com/records/483/forcemech-international-llc/d4c70c2c-df53-4f62-bc63-b16b8a37a8b0

> FDA 483 for Forcemech International LLC on April 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Forcemech International LLC
- Inspection Date: 2021-04-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Forcemech International LLC, a relabeler/repacker of power wheelchairs in Pearland, TX, received a Form FDA-483 with 11 observations. The inspection revealed severe deficiencies across its quality system, including inadequate procedures for MDR reporting, complaint handling, incoming product acceptance, corrective and preventive actions, rework, servicing, supplier control, nonconforming product, quality audits, management review, and employee training. Several observations were repeats from a previous inspection, indicating a persistent failure to establish and implement a compliant quality system.

## Related Documents

- [483 - 2020-03-17](https://www.keypedia.com/records/483/forcemech-international-llc/47e49ed8-f041-4887-84b3-41c5e64f32ed)
- [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/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab