# FDA 483 - Good Clean Love, Inc. - June 13, 2019

Source: https://www.globalkeysolutions.net/records/483/good-clean-love-inc/72d0425f-b5cb-413d-b0ec-e6282d3c8a03

> FDA 483 for Good Clean Love, Inc. on June 13, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Good Clean Love, Inc.
- Inspection Date: 2019-06-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Good Clean Love, Inc., a manufacturer of the BioNude Ultra Sensitive Personal Lubricant (a Class 2 medical device), was cited for three observations during an FDA inspection. The firm failed to perform a required risk analysis for the BioNude device, lacked adequate procedures for evaluating design changes for regulatory impact, and did not properly maintain its device master record with correct product specifications. These issues indicate deficiencies in the firm's quality system for medical device development and control.

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/good-clean-love-inc/a5a9b6ac-5e18-4498-aaaa-0e65d22c6afe

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822