# FDA 483 - AVASOL LLC - February 12, 2025

Source: https://www.keypedia.com/records/483/avasol-llc/44918a57-7b24-4d71-8b3d-1151d24e5d85

> FDA 483 for AVASOL LLC on February 12, 2025. Product: cosmetics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AVASOL LLC
- Inspection Date: 2025-02-12
- Product Type: cosmetics
- Office Name: Los Angeles District Office
- Summary: AVASOL LLC in Santa Barbara, CA, was issued a Form 483 with four observations following an FDA inspection. The firm demonstrated significant deficiencies in its quality control unit, including incomplete and unfollowed procedures for process validations, equipment qualifications, and cleaning validations. Additionally, the inspection revealed issues with equipment cleaning logs, instrument calibration procedures, and the investigation of unexplained discrepancies, indicating a lack of robust quality system controls for drug product manufacturing.

## Related Documents

- [483 - 2023-11-09](https://www.keypedia.com/records/483/avasol-llc/9e0fe5ba-2be8-4488-8a38-4e70286e608c)

## Related Officers

- [Sara H. Gabel](https://www.keypedia.com/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b