# FDA 483 - InControl Medical, LLC - August 21, 2012

Source: https://www.globalkeysolutions.net/records/483/incontrol-medical-llc/cc5576ca-e122-4961-812a-e29a8cf68226

> FDA 483 for InControl Medical, LLC on August 21, 2012. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InControl Medical, LLC
- Inspection Date: 2012-08-21
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: InControl Medical, LLC, a medical device manufacturer in Brookfield, WI, was inspected by the FDA from August 14-21, 2012. The inspection revealed significant deficiencies across its quality system, including inadequate organizational structure, lack of quality audits, and widespread issues with design controls, device records, process validation, training, and document control for its InTone medical device. These observations indicate a fundamental failure to establish and maintain a compliant quality system.

## Related Documents

- [WARNING_LETTER - 2012-08-21](https://www.globalkeysolutions.net/records/warning_letter/incontrol-medical-llc/9b7abece-aca0-40c3-8226-b3ed6e4b6802)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.globalkeysolutions.net/companies/incontrol-medical-llc/42053149-a27e-4714-8c2e-6fa5dbcb43da

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d