cdj holding, inc., – FDA Warning Letter, Mar 27, 2013

The FDA conducted an inspection of CDJ Holding, Incorporated, d.b.a. Pacific BioLogic, from March 14-27, 2013, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111).

Several products, including Grounded, Limbic Balance Morning/Evening Formula, TobacOff, and JittersAway, are deemed unapproved new drugs due to therapeutic claims in their labeling, violating sections 201(g)(1)(B), 201(p), 505(a), and 301(d) of the Act. Additionally, Grounded, Limbic Balance Morning/Evening Formula are misbranded drugs under section 502(f)(1) for lacking adequate directions for layperson use.

All dietary supplement products are adulterated under section 402(g)(1) due to CGMP violations. Specific CGMP deficiencies include: 1. Failure to establish specifications for components, finished products, and packaging/labels (21 CFR 111.70(a), (b)(1), (b)(2), (e), 111.80(a)). 2. Incomplete batch production records, lacking manufacturing dates and actual yields (21 CFR 111.255(b), 111.260