FDA WARNING_LETTER - Prodimed SAS - July 02, 2015

On November 2, 2015, the FDA issued a Warning Letter to Prodimed SAS following an inspection from June 29 to July 2, 2015. The inspection revealed that the firm's endometrial sampling devices, embryo transfer sets, insemination cannulas, and oocyte puncture systems were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

Violations included: 1. **Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d))**: Endotoxin testing for sterilization family 3a (Oocyte Puncture System) was not conducted between February and October 2014, despite over 10,000 devices being distributed. The firm also lacked a statistical rationale for its sampling plan. The firm's response, planning to revise procedures and test all US-destined lots, was deemed inadequate without completion documentation. 2. **Failure to validate processes (21 CFR 820.75(a))**: The firm did not validate the bonding process for tubes and fittings. The response, stating plans to qualify and validate the process, was inadequate as it lacked a risk assessment for distributed devices and completion documentation. 3. **Failure to control environmental conditions