# FDA 483 - Medwaves Inc - September 11, 2023

Source: https://www.globalkeysolutions.net/records/483/medwaves-inc/df38303e-43fb-436e-8945-fe4de9a782a1

> FDA 483 for Medwaves Inc on September 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medwaves Inc
- Inspection Date: 2023-09-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Medwaves Inc, a medical device manufacturer in San Diego, CA, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in the firm's quality system, specifically regarding inadequate employee training procedures and a lack of established process controls for product storage. These issues indicate a need for improved adherence to regulatory requirements.

## Related Officers

- [Jenny L. Chisem](https://www.globalkeysolutions.net/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.globalkeysolutions.net/companies/medwaves-inc/3db6ccb5-cfda-4bb9-9f5e-e25b0f50bd97

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6