# FDA 483 - Algomedica, Inc. - August 22, 2019

Source: https://www.globalkeysolutions.net/records/483/algomedica-inc/6db16eae-4987-45ff-b56f-a00b1403b0be

> FDA 483 for Algomedica, Inc. on August 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Algomedica, Inc.
- Inspection Date: 2019-08-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Alqemedica, Inc., a medical device manufacturer in Sunnyvale, CA, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, design reviews, and management reviews. Additionally, issues were noted with documenting device installations and maintaining proper document control, indicating a broad lack of adherence to quality system regulations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.globalkeysolutions.net/companies/algomedica-inc/2546b6aa-3211-4e18-8530-0bbf6b9690d0

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b