The FDA issued a warning letter to Dallas-based manufacturer EEMSO for "significant violations" of the quality system (QS), including medical device reporting (MDR) and device listing regulations.
According to the letter, the firm failed to maintain QS records and MDR procedures for three products: the E-Strip disposable iontophoretic (alternative drug delivery system in which a low-level electrical current is applied to a similarly charged drug solution) treatment system, two models of a high-voltage galvanic stimulator, and the M2 series wireless transcutaneous electrical nerve stimulator. The firm also failed to submit a device listing for the E-Strip.
As a result of the violations, all three products were declared adulterated and misbranded, according to the letter. The agency's warning letter was the result of inspections conducted in January and February at EEMSO's Dallas facility. In the letter, FDA inspectors reported the following QS violations: the absence of GMP records for inspection; failure to maintain device master records, batch history records and rejection criteria; and failure to maintain service records for leased devices that have been returned for redistribution.According to the warning letter, FDA inspectors also found that EEMSO did not evaluate the work of a foreign firm contracted to manufacture the E-Strip. This foreign firm later subcontracted another unevaluated foreign agency to perform the actual manufacturing.
Furthermore, neither foreign contractor was registered to export the E-Strip and galvanic stimulator devices, the letter stated. The names and locations of the two foreign companies were not disclosed. In addition to the QS and device-listing violations, EEMSO failed to maintain written procedures for receiving, reviewing and evaluating complaints, the letter stated.
The agency warned EEMSO that new products would not receive premarket approval if related QS deficiencies were not redressed. A failure to correct the violations may also result in seizure, injunction or other regulatory action, the agency wrote. EEMSO has 15 business days from receipt of the warning letter to correct the violations.
Phone calls to the firm requesting comment were not returned. To view the warning letter, visit http://www.fda.gov/foi/warning_letters/g5791d.htm (http://www.fda.gov/foi/warning_letters/g5791d.htm). ()a href="http://www.fdanews.com/ddl/33_16/" target=_blank>