# FDA 483 - RADIANCE BEAUTY & WELLNESS INC. - April 28, 2023

Source: https://www.globalkeysolutions.net/records/483/radiance-beauty-wellness-inc/a27e453d-6a4c-4763-9feb-9c1b4c827bf0

> FDA 483 for RADIANCE BEAUTY & WELLNESS INC. on April 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RADIANCE BEAUTY & WELLNESS INC.
- Inspection Date: 2023-04-28
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: RADIANCE BEAUTY & WELLNESS INC. in Chatsworth, CA, was inspected and found to have significant deficiencies across its quality control unit, laboratory controls, and batch record management. The firm failed to establish a proper QCU, conduct essential raw material and in-process testing, maintain adequate records for rejected materials and manufacturing processes, and implement a stability program for its OTC drug products. These issues indicate a severe lack of adherence to GMP practices, posing a risk to product quality and patient safety.

## Related Officers

- [Claudia M. Perez-Kasmarski](https://www.globalkeysolutions.net/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.globalkeysolutions.net/companies/radiance-beauty-wellness-inc/afe5ef3a-cbb8-4279-b2fb-6cf8f62f62be

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