# FDA 483 - Companion Medical, Inc. - August 14, 2019

Source: https://www.keypedia.com/records/483/companion-medical-inc/5a8bb608-4086-451d-b22f-9abf06da008d

> FDA 483 for Companion Medical, Inc. on August 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Companion Medical, Inc.
- Inspection Date: 2019-08-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Companion Medical, Inc., a medical device manufacturer in San Diego, CA, received a Form 483 for significant quality system deficiencies during an FDA inspection. Observations included inadequate corrective and preventive action procedures, failure to follow procedures for nonconforming product disposition, and a complete lack of Device Master Records for its Class II medical devices. These issues indicate a systemic breakdown in maintaining essential quality system controls.

## Related Officers

- [Jenny L Mccardell](https://www.keypedia.com/people/jenny-l-mccardell/b8fa04db-6acc-48d1-b0be-56777704ae51)

Company: https://www.keypedia.com/companies/companion-medical-inc/aafe4d6f-4c3d-4aa8-9492-872f4a80a058

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