FDA 483 - Anesta LLC - August 30, 2024

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.