# FDA 483 - Upsher-Smith Laboratories, LLC - November 07, 2019

Source: https://www.keypedia.com/records/483/upsher-smith-laboratories-llc/e4f1278e-2e82-4271-8267-fc098e6954ef

> FDA 483 for Upsher-Smith Laboratories, LLC on November 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Upsher-Smith Laboratories, LLC
- Inspection Date: 2019-11-07
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of USL Pharma Inc. dba Upsher-Smith Laboratories, LLC in Denver, CO, a drug manufacturer, revealed significant deficiencies in quality control and sanitation practices. Observations included failures to thoroughly investigate unexplained discrepancies related to equipment cleanliness and microbial contamination, as well as a lack of established procedures to prevent objectionable microorganisms in non-sterile drug products. These findings suggest potential risks to drug product quality and patient safety.

## Related Officers

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.keypedia.com/companies/upsher-smith-laboratories-llc/abe71588-9a29-43ec-9663-eabd373c78c5

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face