Western Innovations, Inc.
FDA issued a warning letter to Western Innovations, Inc. (Denver, CO) following a January–February 2024 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations under 21 CFR Part 111, including failures to establish component specifications, written quality control procedures, proper master manufacturing records, and complete batch production records for their Acetyl-glutathione product. These violations render the dietary supplements adulterated under section 402(g)(1) of the FD&C Act, and FDA warned that failure to correct them may result in seizure or injunction.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations.
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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