FDA WARNING_LETTER - Basic Organics, Inc. - April 06, 2012

The FDA inspected Basic Organics Inc. from March 26 to April 6, 2012, finding serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111) for their dietary supplement packaging, labeling, holding, and distributing operations. This rendered their Glucosamine Chondroitin and Omega 3 products adulterated. The firm, a distributor of contract-manufactured supplements, was reminded of its ultimate responsibility for manufacturing and direct responsibility for its own operations, despite claiming exemption. Violations included: failure to identify quality control personnel and establish written QC procedures (21 CFR 111.12(b), 111.103); lack of Master Manufacturing Records for packaging/labeling (21 CFR 111.205(b)(1)) and associated specifications (21 CFR 111.70(a)); absence of written procedures for returned products (21 CFR 111.503), product complaints (21 CFR 111.553), and holding/distributing operations (21 CFR 111.453). Other deficiencies involved not collecting reserve samples (21 CFR 111.83(a)), incomplete Batch Production Records (21 CFR 111.255(b)), failure to establish and record incoming supplier specifications (21 CFR 111.70(f), 111.95(b)(1)), and lack of readily available manufacturing records (21 CFR 111.610) and written personnel procedures (21 CFR 111.8, 111.10). The firm's initial response was inadequate. Basic Organics Inc. must submit a detailed corrective action plan with supporting documentation within fifteen working days to avoid enforcement actions like seizure or injunction.