Technomed Europe – FDA Warning Letter, Jun 12, 2008

On September 17, 2008, the FDA issued a Warning Letter to Technomed Europe following an inspection from June 9-12, 2008, at their Maastricht, Netherlands facility. The inspection determined that Technomed Europe manufactures Diagnostic Electromyograph Needles, Radiofrequency Lesion Probes, Needle Electrodes, Cutaneous Electrodes, and Nasopharyngeal Electrodes, which are classified as devices under the Federal Food, Drug, and Cosmetic Act.

The inspection revealed that these devices are adulterated because the manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Specific violations include: 1. **Failure to validate and approve a manufacturing process (21 C.F.R. 820.75(a))**: The spot welding process using the [(b)(4)] Spot Welder [(b)(4)] lacked documented Installation Qualification (IQ) or Performance Qualification (PQ) before production use. 2. **Failure to document corrective and preventive action activities (21 C.F.R. 820.100(b))**: No documentation existed for CAPA activities related to three complaints [(b)(a)] and four nonconformance cases [(b)(4)] where CAP