# FDA 483 - Wellington Foods Incorporated - October 11, 2024

Source: https://www.globalkeysolutions.net/records/483/wellington-foods-incorporated/749994bd-21c0-4662-8b40-968ea32c6923

> FDA 483 for Wellington Foods Incorporated on October 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wellington Foods Incorporated
- Inspection Date: 2024-10-11
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Wellington Foods Incorporated, a contract manufacturing organization in Corona, CA, was cited for significant deficiencies during an FDA inspection. The firm released OTC drug products that exceeded microbial specifications, failed to adequately validate its water system for pharmaceutical manufacturing, and did not investigate temperature excursions in its finished drug product warehouse. These issues indicate a failure to ensure drug product quality and adherence to established procedures.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/wellington-foods-incorporated/7a80f779-dac3-4c69-9766-17dc5900c26d

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