FDA WARNING_LETTER - Okamoto Industries, Inc. - July 23, 2015

On November 23, 2015, the FDA issued a Warning Letter to Okamoto Industries, Inc. following an inspection from July 20-23, 2015, which found their natural rubber latex condoms to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

The inspection revealed several violations: 1. **Failure to establish and maintain design validation procedures (21 CFR 820.30(g))**: The firm's design control procedure did not require design validation on initial production units, and the Okamoto Ultra-Thin Male Natural Latex Condom (JN-N42), distributed since 2010, lacked design validation. 2. **Failure to validate processes (21 CFR 820.75(a))**: The compounding/mixing processes for LS-Type condoms using (b)(4) mixing tanks were not validated. 3. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The CAPA procedure lacked requirements for analyzing quality data to identify nonconforming product causes, and such analysis was not performed. 4. **Failure to control environmental conditions (21 CFR 820.70(c))**: A dirty