9mm Special Effects – FDA Warning Letter, Sep 30, 2014

This FDA Warning Letter, dated May 19, 2015, addresses 9mm Special Effects following an inspection from September 8-30, 2014, which revealed the firm manufactures decorative contact lenses, classified as devices.

The firm is cited for marketing an unapproved device, violating 21 U.S.C. § 351(f)(1)(B) and § 352(o), as no premarket approval (PMA) or 510(k) notification was submitted. The devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820), including failures in corrective/preventive actions (21 CFR 820.100), design control (21 CFR 820.30(a)), process validation (21 CFR 820.75(a)), production process control (21 CFR 820.70(a)), quality system procedures (21 CFR 820.20(e)), purchasing controls (21 CFR 820.50), and handling procedures (21 CFR 820.140).

Additionally, the devices are misbranded under 21 U.S.C. §