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For instance, individuals with the AS3MT rs9527 variant are considered slow methylators, which results in elevated monomethylarsonic acid (MMA) levels and heightened risk of systemic toxicity [80, 81]

Subsections (a) and (d) of 21 CFR 211.22 were specifically cited by the agency, demonstrating the emphasis the agency has placed on deficiencies in the functionality of quality units