# FDA 483 - United Guardian Inc - September 04, 2025

Source: https://www.keypedia.com/records/483/united-guardian-inc/333a767a-5614-4423-9235-8f5c11185c14

> FDA 483 for United Guardian Inc on September 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Guardian Inc
- Inspection Date: 2025-09-04
- Product Type: drugs
- Office Name: New York District Office
- Summary: United-Guardian, Inc. in Hauppauge, NY, a pharmaceutical drug manufacturer, was inspected and cited for multiple significant deficiencies. Observations included failures in data integrity controls, inadequate production and process control procedures, neglected annual product reviews, improper drug product storage conditions, and insufficient equipment qualification and maintenance. These issues indicate a lack of robust quality systems and adherence to cGMP requirements.

## Related Documents

- [483 - 2018-08-02](https://www.keypedia.com/records/483/united-guardian-inc/f7a82918-779a-4dd0-8bcc-4a7b378a573a)
- [483 - 2025-09-04](https://www.keypedia.com/records/483/united-guardian-inc/d01959f6-92af-46fb-89ff-9e6fbe93da44)

## Related Officers

- [investigator](https://www.keypedia.com/people/divek-r-jumani/ba9b28e9-d9b3-4c9f-8532-25f037ff7ce4)

Company: https://www.keypedia.com/companies/united-guardian-inc/e0618d2b-193e-4f0f-aaf8-f186250a177e

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d