FDA WARNING_LETTER - Prismic Light International, Inc. - January 23, 2012

An FDA inspection of Prismic Light International's facility in Murfreesboro, Tennessee, in January 2012, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products adulterated. The firm's Cell Renew and Cell Silver products were also found to be promoted with therapeutic claims, classifying them as unapproved new drugs under Sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act, and illegally marketed without FDA approval per Section 505(a).

Key CGMP deficiencies included the failure to implement production/process controls, properly handle in-process materials, establish specifications, verify ingredient identity, establish quality control procedures, prepare master manufacturing and batch production records, collect reserve samples, establish equipment procedures (including calibration), maintain cleaning/pest control records, and establish procedures for product complaints and returns. Additionally, Cell Renew, Cell Renew Essential Silica, and Cell Silver products were misbranded under Section 403 due to non-compliant nutrition labeling (21 CFR 101.36), failure to identify as dietary supplements (21 CFR 101.3(g)), and omission of a domestic address/phone number for adverse event reporting (Section 403(y)). Other issues included inadequate handwashing facilities (21 CFR 111.15(i)), improper labeling of export products (Section 801(e)), and unclean manufacturing equipment (21 CFR 111.27(d)). The FDA requires prompt corrective action within 15 working days, including documentation and a plan to prevent recurrence, warning of potential legal action like seizure or injunction.