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

Source: https://www.keypedia.com/records/warning_letter/okamoto-industries-inc/582a7a9c-890b-439e-9a2b-207dddc76608

> FDA WARNING_LETTER for Okamoto Industries, Inc. on July 23, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Okamoto Industries, Inc.
- Inspection Date: 2015-07-23
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [US Agent](https://www.keypedia.com/people/hisayuki-naito/02622179-0e68-42af-8753-b7b9b5b42d4b)
- [Office Director](https://www.keypedia.com/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)

Company: https://www.keypedia.com/companies/okamoto-industries-inc/398388ea-77dd-4a73-b525-a7a3a0590996

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7