# FDA 483 - CC Wellness, LLC - November 15, 2023

Source: https://www.globalkeysolutions.net/records/483/cc-wellness-llc/142b0ae5-588b-428d-800c-ed8b72b11366

> FDA 483 for CC Wellness, LLC on November 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CC Wellness, LLC
- Inspection Date: 2023-11-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CC Wellness, LLC, a drug product manufacturer in Valencia, CA, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality systems, including inadequate written procedures for equipment maintenance and process controls, a failure to conduct thorough investigations into discrepancies, and a lack of annual product reviews. Additionally, the quality control unit's responsibilities and the change control system were found to be insufficient.

## Related Officers

- [Rowena S. Nguyen](https://www.globalkeysolutions.net/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

Company: https://www.globalkeysolutions.net/companies/cc-wellness-llc/fce04938-7871-4b68-8ab4-58b7a2669025

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