483
Chae Organics LLCChae Organics LLC – FDA 483, Mar 14, 2025
Record Details
Chae Organics LLC, a manufacturer in Walsenburg, CO, was cited for significant deficiencies in its quality control and stability testing practices for OTC drug products. The firm failed to establish appropriate expiration dates based on reliable stability data and lacked adequate preservative efficacy testing. Additionally, the company did not conduct annual product reviews as required.
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ID · b3bac52d-9069-4891-8c74-a21d627211ad
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