# FDA 483 - United Laboratories Manufacturing, LLC - August 26, 2016

Source: https://www.keypedia.com/records/483/united-laboratories-manufacturing-llc/22f9bec9-d67d-4c75-aa63-28883f248043

> FDA 483 for United Laboratories Manufacturing, LLC on August 26, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Laboratories Manufacturing, LLC
- Inspection Date: 2016-08-26
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: United 1 International Laboratories, LLC, an OTC drug manufacturer in Carrollton, TX, was inspected by the FDA. The inspection revealed two significant observations related to the firm's quality system and equipment maintenance. Specifically, the firm lacked established procedures for annual product reviews and failed to follow written procedures for cleaning validation of manufacturing equipment.

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## Related Officers

- [ Investigator ](https://www.keypedia.com/people/patrice-s-hall/b58acfc0-fa18-4425-9a51-92267a2a6491)

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