# FDA 483 - DRW Medical - April 07, 2025

Source: https://www.keypedia.com/records/483/drw-medical/f14f0cfd-1323-4abf-9061-370c3b1a9c99

> FDA 483 for DRW Medical on April 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DRW Medical
- Inspection Date: 2025-04-07
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: DRW Medical, a manufacturer in Aston, PA, was inspected regarding its Class II NAPA LP-15 Airway Pressure monitor. The inspection revealed significant deficiencies in the firm's design control process, including a failure to complete required design input, output, and transfer checklists. Additionally, the firm lacked adequate justification or validation for software changes made to the device, raising concerns about its safety and effectiveness for neonates.

## Related Officers

- [Nadia R. Barreda](https://www.keypedia.com/people/nadia-r-barreda/ef624359-957a-45e4-89c9-5b5ff215c6aa)

Company: https://www.keypedia.com/companies/drw-medical/66dd3b1b-f5d6-4567-bd39-4384cc65922e

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8