# FDA 483 - Nutraluxe Global, LLC #1 - March 15, 2019

Source: https://www.globalkeysolutions.net/records/483/nutraluxe-global-llc-1/72e7135d-6569-476a-9c87-e9262fd7915d

> FDA 483 for Nutraluxe Global, LLC #1 on March 15, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nutraluxe Global, LLC #1
- Inspection Date: 2019-03-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pulsaderm, LLC, a medical device manufacturer in Fort Myers, FL, received a Form FDA-483 with four observations during an inspection. The firm was cited for deficiencies in its quality system, specifically regarding complaint handling, corrective and preventive actions, design validation, and document control. These issues indicate a need for significant improvements in the firm's procedural adherence and record-keeping practices.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/nutraluxe-global-llc-1/819f2104-d705-428f-b7e4-b4f9b6ffbe4c

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6