# FDA 483 - United Laboratories Manufacturing, LLC - April 09, 2018

Source: https://www.keypedia.com/records/483/united-laboratories-manufacturing-llc/fbf0f238-6c4f-4290-9f63-fe3e4d0e2bf1

> FDA 483 for United Laboratories Manufacturing, LLC on April 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Laboratories Manufacturing, LLC
- Inspection Date: 2018-04-09
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of United I International Laboratories, LLC, an OTC drug manufacturer in Carrollton, TX, revealed multiple significant deficiencies in their quality control and record-keeping practices. Observations included failures to record and investigate deviations, use of incorrect master batch records, incomplete laboratory and in-process control results, and inadequate equipment and cleaning logs. These issues indicate a systemic lack of adherence to good manufacturing practices.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/shelby-n-marler/2cbb1b1c-ad36-4385-b61f-bee80ad8e1bd)
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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