# FDA 483 - United Laboratories Manufacturing, LLC - August 18, 2010

Source: https://www.keypedia.com/records/483/united-laboratories-manufacturing-llc/d041396b-28e2-41f2-9b41-1171ac6d1d0c

> FDA 483 for United Laboratories Manufacturing, LLC on August 18, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Laboratories Manufacturing, LLC
- Inspection Date: 2010-08-18
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of United 1 International Laboratories, LLC in Farmers Branch, TX, an OTC contract drug manufacturer and dietary supplement producer, revealed significant deficiencies across multiple quality systems. The firm failed to adequately validate manufacturing processes, computer systems, and equipment, and did not follow its stability testing program for OTC drugs. Additionally, issues were noted in dietary supplement manufacturing regarding identity testing, corrective action plans, complaint investigations, and contamination control, indicating a broad lack of adherence to good manufacturing practices.

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## Related Officers

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Company: https://www.keypedia.com/companies/united-laboratories-manufacturing-llc/973d4b48-b42b-4418-b827-ed52d8881802

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9