FDA WARNING_LETTER - Big Easy Confections, L.L.C. - May 14, 2014

An FDA inspection of Big Easy Confections, LLC from May 5-14, 2014, revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR 111), rendering products, including "(b)(4)", adulterated. The "(b)(4)" dietary supplement was also found to be misbranded under Section 403 of the Act and 21 CFR 101. CGMP deficiencies included failures to conduct identity testing for dietary ingredients, qualify suppliers, establish required specifications for manufacturing and finished products, prepare and follow Master Manufacturing Records (MMRs) and Batch Production Records (BPRs), establish and follow written quality control procedures (including documentation of QC reviews), quarantine components, and establish written procedures for packaging, labeling, holding, distributing, returned dietary supplements, product complaints, and instrument calibration. The firm's responses were deemed inadequate due to a lack of supporting documentation. Misbranding violations for the "(b)(4)" product involved the absence of a domestic address/phone number for adverse event reporting (Section 403(y)), failure to identify the product as a "dietary supplement" (Section 403(s)(2)(B)), and omission of the manufacturer's name and place of business (Section 403(e)(1)). The FDA requires prompt corrective action within fifteen working days, including documentation, to prevent legal action such as seizure or injunction, and potential reinspection fees. The letter also noted that any "best by" dates must be supported by stability data.