# FDA 483 - Space Maintainers Lab - September 17, 2021

Source: https://www.globalkeysolutions.net/records/483/space-maintainers-lab/a21031d1-209b-4544-aa01-61ba53dc87f4

> FDA 483 for Space Maintainers Lab on September 17, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Space Maintainers Lab
- Inspection Date: 2021-09-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Space Maintainers Lab in Chatsworth, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm was cited for failing to establish adequate procedures for design control, process control, and employee training. These issues indicate a lack of fundamental controls necessary for ensuring medical device quality and compliance.

## Related Documents

- [483 - 2024-10-03](https://www.globalkeysolutions.net/records/483/space-maintainers-lab/e4807821-5eaf-45da-a0a1-e04f02024ef4)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/space-maintainers-lab/f6061320-02e0-4445-a57b-f0f726bd2139

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