# FDA WARNING_LETTER - 9mm Special Effects - September 30, 2014

Source: https://www.globalkeysolutions.net/records/warning_letter/9mm-special-effects/b89c0013-7fc1-447d-827e-563844f88cf8

> FDA WARNING_LETTER for 9mm Special Effects on September 30, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: 9mm Special Effects
- Inspection Date: 2014-09-30
- Product Type: Devices
- Office Name: San Francisco District Office
- Summary: 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. §

## Related Officers

- [Kathleen M. Lewis](https://www.globalkeysolutions.net/people/kathleen-m-lewis/c7f66b1a-d346-48cc-ab84-9ea6c2805268)

Company: https://www.globalkeysolutions.net/companies/9mm-special-effects/d85e27df-26af-4f3c-a094-2b40bb9b9598

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df