FDA WARNING_LETTER - Sure On Industries Ltd. - May 31, 2012

On August 6, 2012, the FDA issued a Warning Letter to Sure On Industries Ltd. following an inspection from May 28-31, 2012, at their Dong Guan City, China facility. The inspection revealed that the firm, which manufactures non-sterile surgical pleated masks, respirators (including N95 Healthcare Particulate Respirators), and examination gowns, was not in conformity with Quality System (QS) regulation (21 CFR Part 820). The devices were deemed adulterated under section 501(h) of the Act.

The firm's June 15, 2012 response to the FDA 483 was inadequate, as it only stated that "CAR reports" for the six observations would be submitted by July 2012, lacking information on systemic corrective actions.

Violations included: 1. Failure to establish adequate process validation procedures (21 CFR 820.75(a)), specifically lacking written protocols and reports for N95 particulate respirators. 2. Failure to establish and maintain design validation procedures, including risk analysis (21 CFR 820.30(g)). 3. Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)), including not following sampling methods for testing. 4. Failure to develop, conduct, control, and monitor