Mericon Industries, Inc.
FDA issued a warning letter to Mericon Industries, Inc. (Peoria, IL) following a facility inspection and website review, finding that its Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 Capsules were marketed with disease-treatment claims (notably osteoporosis prevention and remediation) that rendered them unapproved new drugs under the FD&C Act. The products were also found to be misbranded drugs (lacking adequate directions for use), adulterated dietary supplements (due to serious CGMP violations including absent finished-product identity specifications and inadequate batch records), and misbranded dietary supplements (non-compliant nutrition labeling). FDA warned that failure to correct these violations may result in seizure or injunction, and required a written response within 15 working days.
Flagged claims (1)
Prevention and remediation of osteoporosis.
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. 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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