# FDA 483 - Noble Panacea Labs, Inc. - November 08, 2024

Source: https://www.keypedia.com/records/483/noble-panacea-labs-inc/81ab6b58-7ef1-49bd-a661-07cabd76e40d

> FDA 483 for Noble Panacea Labs, Inc. on November 08, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Noble Panacea Labs, Inc.
- Inspection Date: 2024-11-08
- Product Type: Drugs
- Summary: From November 4-8, 2024, FDA investigators Rowena S Nguyen and Rachel C Stanton inspected Noble Panacea Labs, Inc., a manufacturer located at 28 Hammond Ste E, Irvine, CA 92618-1661. The inspection identified 11 observations regarding the firm's compliance with Good Manufacturing Practices (GMP) for drug products, specifically concerning their OTC drug product, The Energist Multi-Defense Cream Broad Spectrum Sunscreen SPF 50 (1.1mL).

Key observations include:

1.  **Lack of Established Written Procedures for Production and Process Controls:**
    *   No process validation for The Energist Multi-Defense Cream Broad Spectrum Sunscreen SPF 50 (1.1mL).
    *   Water system (NPL-EQ-[b][4]) not validated or adequately monitored; issues with testing frequency justification, unqualified personnel for microbial testing, and lack of microbial testing in qualification reports. This water was used in manufacturing two bulk lots.
    *   Inadequate cleaning validation reports (VAL-03-00, VAL-04-00) for the [b][4] and sachet filling machines, lacking justification for product selection, demonstration of API removal (zinc oxide), and comprehensive cleaning verification tests.
    *   Absence of procedures for using rejected finished product, testing raw materials, 100% finished product inspection, annual product

## Related Documents

- [483 - 2024-11-08](https://www.keypedia.com/records/483/noble-panacea-labs-inc/f10ae652-83b4-4739-863c-ba1ca0b1855e)

## Related Officers

- [Rachel C. Stanton](https://www.keypedia.com/people/rachel-c-stanton/36495725-366c-4138-a4d8-df3ce38fa9cd)
- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

Company: https://www.keypedia.com/companies/noble-panacea-labs-inc/80c9eee9-c3a9-4d4f-a114-8336d17225b7