Muscle Feast, LLC
FDA issued a warning letter to Muscle Feast, LLC (Nashport, OH) following a December 2021–January 2022 inspection of their dietary supplement manufacturing facility. The agency identified seven serious CGMP violations under 21 CFR Part 111, including failures to establish identity and purity specifications for components and finished products, inadequate quality control review of batch records, and improper reserve sample storage. FDA found these violations caused the company's dietary supplement products to be adulterated under section 402(g)(1) of the FD&C Act, and warned that failure to correct the issues could result in seizure or injunction.
Flagged claims (1)
Your firm includes expiration dates on the labels for the dietary supplement products you manufacture, including your Mocha Flavored Whey Protein Isolate, Lot # 565312302151, with an expiration date of December 30, 2023, and whey protein isolate component, Lot # (b)(4), with an expiration date of July 30, 2023. During the inspection, you informed our investigators that you did not conduct or have any data supporting the expiration dates listed on the product labels.
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 any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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