# FDA 483 - AVASOL LLC - November 09, 2023

Source: https://www.globalkeysolutions.net/records/483/avasol-llc/9e0fe5ba-2be8-4488-8a38-4e70286e608c

> FDA 483 for AVASOL LLC on November 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AVASOL LLC
- Inspection Date: 2023-11-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: AVASOL LLC in Santa Barbara, CA, was inspected and received a Form 483 with seven observations related to significant deficiencies in their manufacturing processes for OTC drug products. The inspection revealed issues across stability studies, process validation, master and batch production records, component identity testing, equipment qualification, and cleaning procedures. These findings indicate a lack of adequate controls to ensure product quality and compliance.

## Related Documents

- [483 - 2025-02-12](https://www.globalkeysolutions.net/records/483/avasol-llc/44918a57-7b24-4d71-8b3d-1151d24e5d85)

## Related Officers

- [Youkeun Kim](https://www.globalkeysolutions.net/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.globalkeysolutions.net/companies/avasol-llc/b0d0f5ce-2270-4cfa-b55c-8e9ea63f27fe

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