# FDA WARNING_LETTER - PI Pharma Inc - February 19, 2014

Source: https://www.keypedia.com/records/warning_letter/pi-pharma-inc/4a90e924-9f1d-47b1-83a6-65f0bb8a0c57

> FDA WARNING_LETTER for PI Pharma Inc on February 19, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: PI Pharma Inc
- Inspection Date: 2014-02-19
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: 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

## Related Officers

- [District Director](https://www.keypedia.com/people/paul-j-teitell/5de80a65-d370-4a60-8080-21befa356d9b)

Company: https://www.keypedia.com/companies/pi-pharma-inc/0e7b38c1-94cc-4e39-b7eb-49df3fa912f3

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22