ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH – FDA Warning Letter, Apr 11, 2013

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)):**