FDA WARNING_LETTER - PI Pharma Inc - February 19, 2014

On February 10-19, 2014, the FDA inspected PI Pharma Inc. (dba Nature's Extra) and found serious violations. Products "Argentia Silver Cream" and "(b)(4)" are unapproved new drugs under 21 U.S.C. § 321(g)(1) and § 321(p) due to therapeutic claims (e.g., "Wound Healing," "Genital Wart Treatment"). Their distribution without FDA-approved applications violates 21 U.S.C. §§ 331(d) and 355(a). "(b)(4)" is also misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use, as genital warts are not amenable to self-treatment.

The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements (21 CFR Part 111), rendering "(b)(4)" dietary supplements adulterated (21 U.S.C. § 342(g)(1)). Violations include: 1. Failure to establish and verify finished product specifications (21 CFR 111.70(e), 111.75(c)). 2. Failure to establish specifications for products received for packaging/labeling (21 CFR 111