# FDA 483 - Nemcomed FW LLC dba Avalign Instruments and Implants - January 16, 2025

Source: https://www.keypedia.com/records/483/nemcomed-fw-llc-dba-avalign-instruments-and-implants/68f517ce-80d9-494a-8f75-a70dd85a4085

> FDA 483 for Nemcomed FW LLC dba Avalign Instruments and Implants on January 16, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nemcomed FW LLC dba Avalign Instruments and Implants
- Inspection Date: 2025-01-16
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Nemcomed FW LLC dba Avalign Instruments and Implants in Fort Wayne, IN, identified a significant issue regarding the inadequate documentation of acceptance activities. Specifically, the firm failed to consistently record the equipment used during these activities, which is crucial for investigating nonconforming products. This deficiency was observed in sampled Device History Records, indicating a systemic problem with record-keeping for critical manufacturing processes.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)
- [Hammam A. Abdallah](https://www.keypedia.com/people/hammam-a-abdallah/fc1ee5c3-b00c-43af-b5a3-1bdc2ad6c5d7)

Company: https://www.keypedia.com/companies/nemcomed-fw-llc-dba-avalign-instruments-and-implants/b0758b28-0d1f-43f5-a1bd-7a8112a5215d

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03