# FDA 483 - Anesta LLC - August 30, 2024

Source: https://www.keypedia.com/records/483/anesta-llc/ed0f44c4-4fe1-4945-a072-2fa1c9ab2722

> FDA 483 for Anesta LLC on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anesta LLC
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Anesta LLC in Salt Lake City, UT, from August 26-30, 2024, revealed two significant observations. Inspectors found unsanitary conditions, including discoloration and mold-like residue, in a walk-in refrigerator used for drug product manufacturing, along with a lack of specific cleaning procedures. Additionally, the firm failed to document production adjustments for a drug batch at the time of performance and did not open a deviation.

## Related Officers

- [Stryker, Regulatory Affairs](https://www.keypedia.com/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)
- [Team Biologics Staff](https://www.keypedia.com/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.keypedia.com/companies/anesta-llc/821f19a7-cabd-47ab-a635-7880a3c5046d

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