# FDA 483 - Biospace Inc. - April 22, 2019

Source: https://www.globalkeysolutions.net/records/483/biospace-inc/d519fbdd-3c68-4921-b0c1-ceb88fb891e1

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

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## Details

- Record Type: 483
- Company Name: Biospace Inc.
- Inspection Date: 2019-04-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Biospace Inc., a medical device manufacturer in Los Angeles, CA, revealed two significant observations. The firm failed to document acceptance activities, specifically quality inspections of received devices. Additionally, Biospace Inc. had not established its own procedures for corrective and preventive actions (CAPA).

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/juanita-banuelos/b8b581ef-b9f3-4d77-a9fa-691223dbb7f4)
- [Kevin N. Tran](https://www.globalkeysolutions.net/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.globalkeysolutions.net/companies/biospace-inc/4042ddba-8a1b-40ae-83b8-1a36c1097450

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