FDA WARNING_LETTER - Irenda Corporation - September 17, 2012

The FDA conducted an inspection of Irenda Corporation's dietary supplement manufacturing facility from September 12-17, 2012, identifying significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111. These deficiencies render products like L-Carnitine and Co-Q 10 with L-Carnitine adulterated. Key violations include the firm's failure to conduct identity testing for dietary ingredient components (21 CFR 111.75(a)(1)(i)) and other components, or to qualify supplier Certificates of Analysis (21 CFR 111.75(a)(2)). The company also failed to verify that finished batches met product specifications for identity, purity, strength, and composition (21 CFR 111.75(c)(1)), and did not document equipment calibration (21 CFR 111.35(b)(3)). Further issues involved improper storage conditions leading to potential mix-up or contamination (21 CFR 111.455(c)), inadequate physical plant maintenance (e.g., chipped ceilings, leaks, standing water) (21 CFR 111.15(b)(2)), and poor sanitation practices attracting pests (21 CFR 111.15(a)(1)). Additionally, the firm lacked supporting data for "Best if used by" dates on product labels. Irenda Corporation must promptly correct these violations and respond within fifteen working days, detailing corrective actions and providing documentation, to avoid potential enforcement actions like seizure or injunction, and reinspection fees.