Pure Encapsulations, Inc. – FDA Warning Letter, Aug 24, 2011

On August 4-24, 2011, the FDA inspected Pure Encapsulations, Inc., a dietary supplement facility, finding serious CGMP violations (21 CFR Part 111) causing their PhytoBalance products to be adulterated under 21 U.S.C. § 342(g)(1). Product labeling also violated 21 CFR 101.

Violations included: 1. Failure to reject components ((b)(4) and (b)(4)) that did not meet identity specifications for PhytoBalance (Lot No. (b)(4)), as required by 21 CFR 111.77(b). The firm also failed to document material review and disposition decisions (21 CFR 111.140(b)(3)). The company's response was inadequate as it did not confirm if the failed lot was retested or provide results. 2. Failure to ensure scientifically valid identity testing methods (21 CFR 111.75(h)(1)). Organoleptic testing of powdered ingredients ((b)(4)) used as FT-NIR library standards was deemed inappropriate for identity verification. The company's response to update FT-NIR analytical standards within six months using verified reference samples was noted for future verification.

Additionally, PhytoBalance was misbranded (21 U.S.C. § 343