Algaen Corporation – FDA Warning Letter, Aug 1, 2012

An FDA inspection of Algaen's facility in Winston Salem, NC, from July 31 - August 1, 2012, and a subsequent review of their website in March 2013, revealed significant violations concerning their AlgaBerry? products. The FDA determined that AlgaBerry? products are promoted with therapeutic claims (e.g., anti-inflammatory, anti-microbial, anti-tumor, anti-cancer, hypertension control, night blindness treatment), classifying them as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act, requiring prior FDA approval. Furthermore, these products are misbranded under section 502(f)(1) because they lack adequate directions for use for laypersons, and their introduction into interstate commerce violates section 301(a). Even if not classified as drugs, the AlgaBerry? products are adulterated dietary supplements under section 402(g)(1) due to multiple Current Good Manufacturing Practice (CGMP) violations (21 CFR 111). Deficiencies included failure to conduct appropriate identity testing for dietary ingredient components (21 CFR 111.75(a)(1)(i)), failure to prepare and follow written master manufacturing records (21 CFR 111.205), and failure to prepare batch production records (21 CFR 111.255). The firm also failed to establish written procedures for quality control operations (21 CFR 111.103) and for personnel, including preventing microbial contamination and ensuring hygienic practices (21 CFR 111.14(b)(1), 21 CFR 111.10(a), 21 CFR 111.10(b)). Additionally, documentation of personnel training was not maintained (21 CFR 111.14(b)(2)). Algaen must promptly correct these violations and implement preventative procedures within 15 working days to avoid enforcement actions like seizure or injunction, and potential reinspection fees.