WASHINGTON— FDA has sent a warning letter to Largo, FL-based Libi Labs Inc., a manufacturer of a green coffee bean weight supplement, outlining significant good manufacturing practice (GMP) violations, as well as repeated inadequate responses to FDA concerning the correction of these infractions.
This latest failure to institute basic GMP requirements and reply adequately to form 483 violation report items focuses on identity testing, supplier qualification, component specifications and stability testing. The manufacturer's responses to FDA on these violations were deemed inadequate because they did not include exact requirements in the applicable sections of the GMP regulation (21 CFR 111).
FDA warned the company the agency has a right to collect re-inspection fees and urged the company to send a more adequate response within 15 days of receipt of the warning letter.
For more details of this letter, visit the Warning Letter Immersion Center.
For more information on GMP compliance, visit the Dietary Supplement GMP Quality Control Compliance Center.