NatureLab Corp.
FDA issued a warning letter to NatureLab Corp. (Carrollton, TX) following inspections in April–May and October 2021 of their dietary supplement manufacturing facility. The agency found serious CGMP violations under 21 CFR Part 111, including failure to establish required specifications, maintain adequate master manufacturing records and batch production records, and implement written complaint procedures, rendering multiple products adulterated. Additionally, numerous products were found misbranded due to incorrect serving size declarations, improper Supplement Facts label formatting, missing statement of identity, absent adverse event contact information, and non-compliant FDA disclaimers. FDA warned that failure to correct these violations may result in seizure or injunction.
Flagged claims (1)
Percent Daily Values based on a 2,000-calorie diet.
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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