# FDA WARNING_LETTER - Ontex Hygieneneartikel Gmbh - April 11, 2013

Source: https://www.keypedia.com/records/warning_letter/ontex-hygieneneartikel-gmbh/6e88c8f5-31c2-4456-87a1-7ec6de5f6ba3

> FDA WARNING_LETTER for Ontex Hygieneneartikel Gmbh on April 11, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ontex Hygieneneartikel Gmbh
- Inspection Date: 2013-04-11
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: Ontex Hygieneneartikel Gmbh, a German manufacturer of tampons and applicators, received an FDA Warning Letter following an April 8-11, 2013 inspection. The FDA determined their devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include:
1.  **Process Validation (21 CFR 820.75(a)):** Lack of written validation procedures for tampon manufacturing, reliance on historical knowledge for production parameters, no formal acceptance criteria, and failure to control out-of-trend production yields. The firm's response was inadequate, not addressing validation procedure establishment or evaluation of other processes.
2.  **Process Monitoring and Control (21 CFR 820.75(b)):** Failure to qualify production parameters for tampon lines, relying on historical knowledge, and lacking documentation of acceptable parameters. Response adequacy is undetermined.
3.  **Design Control (21 CFR 820.30(a)):**

## Related Officers

- [President](https://www.keypedia.com/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)
- [Owner & Operator](https://www.keypedia.com/people/rene-van-de-zande/34d54c16-0fc0-4821-9658-4d31ec4d6ca1)

Company: https://www.keypedia.com/companies/ontex-hygieneneartikel-gmbh/c30d9b97-f682-4cef-8524-3edb684a51ee

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