FDA Warns Dutch Firm for GMP Violations

Technomed Europe failed to validate its manufacturing process and establish procedures to ensure its equipment is routinely calibrated, inspected and maintained, according to an FDA warning letter.

The FDA says the company’s devices—including diagnostic electromyograph needles, radio-frequency lesion probes, and needle, cutaneous and nasopharyngeal electrodes—will be considered adulterated until the violations have been corrected.

During a June 9–12 inspection of the company’s site in Masstricht, Netherlands, an FDA investigator cited several GMP violations with Technomed’s spot welders.

The company did not validate the spot-welding process with a “high degree of assurance” and had no documentation of installation or performance qualifications before putting the machine in production, the letter states.

The company also failed to document corrective and preventive action activities for three complaints and four nonconformance cases. Furthermore, it had no documentation that a specific spot welder was calibrated before production.

The letter is accessible at: www.fda.gov/foi/warning_letters/s6934c.htm.

SOURCE: FDA NEWS