# FDA 483 - RINATI SKIN LLC - September 22, 2022

Source: https://www.keypedia.com/records/483/rinati-skin-llc/1ef86c74-3d20-4c0d-b804-dedc8fe0776e

> FDA 483 for RINATI SKIN LLC on September 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RINATI SKIN LLC
- Inspection Date: 2022-09-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: RINATI SKIN LLC, a manufacturer in Hawthorne, CA, was cited for significant deficiencies in its quality control, laboratory testing, and production record-keeping during an FDA inspection. The firm failed to perform essential identity and strength testing on active ingredients and finished products, did not thoroughly investigate out-of-specification results, and lacked adequate written procedures and documentation for manufacturing processes and stability testing. These issues indicate a systemic breakdown in ensuring product quality and compliance.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.keypedia.com/companies/rinati-skin-llc/24f7a238-790e-445f-9e2f-aa6291813b34

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