# FDA 483 - Green Roads, Inc. dba Clarity Labs - June 17, 2022

Source: https://www.keypedia.com/records/483/green-roads-inc-dba-clarity-labs/d90e4db5-f45f-4288-b22f-497ff5d9efbf

> FDA 483 for Green Roads, Inc. dba Clarity Labs on June 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Green Roads, Inc. dba Clarity Labs
- Inspection Date: 2022-06-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Green Roads, Inc. dba Clarity Labs, an OTC drug manufacturer in Miami, FL, revealed significant deficiencies in their manufacturing processes. The firm failed to establish control procedures for process validation, adequately test drug products to determine expiration dates, and fully implement quality control unit procedures for OTC drug products. These issues indicate a lack of robust quality systems for ensuring product quality and stability.

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/green-roads-inc-dba-clarity-labs/c1c2a7b4-79a9-48d8-a362-9b8e7379e9ed

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