# FDA 483 - BOX MEDICAL SOLUTIONS INC. - January 30, 2020

Source: https://www.globalkeysolutions.net/records/483/box-medical-solutions-inc/a4cb9849-64e1-489b-9a6b-1895934bd982

> FDA 483 for BOX MEDICAL SOLUTIONS INC. on January 30, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BOX MEDICAL SOLUTIONS INC.
- Inspection Date: 2020-01-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of BOX MEDICAL SOLUTIONS INC. in Thousand Oaks, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for incomplete validation of device software, a lack of established design control procedures, and inadequate procedures for finished device acceptance. These issues indicate a moderate level of non-compliance with regulatory requirements for medical device manufacturing.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.globalkeysolutions.net/companies/box-medical-solutions-inc/8d1727f6-6a6f-4691-bc48-c8205d32b62d

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