# FDA 483 - Forcemech International LLC - April 06, 2023

Source: https://www.keypedia.com/records/483/forcemech-international-llc/cbad169b-d8b7-4ab4-890c-7b1736b946f9

> FDA 483 for Forcemech International LLC on April 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Forcemech International LLC
- Inspection Date: 2023-04-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Forcemech International LLC, a medical device repackager/relabeler in Pearland, TX, was cited for three observations during an FDA inspection. The firm failed to adequately examine labeling for accuracy, including Unique Device Identifiers (UDI), and did not establish sufficient procedures for servicing activities. Additionally, the device master record was not adequately maintained, specifically regarding labeling artwork for serial numbers on powered wheelchairs.

## Related Documents

- [483 - 2020-03-17](https://www.keypedia.com/records/483/forcemech-international-llc/47e49ed8-f041-4887-84b3-41c5e64f32ed)
- [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)

## Related Officers

- [Ellen J. Tave](https://www.keypedia.com/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

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