FDA: Company 'Operating Without Any Quality System'

E Med Future has operated for the past two years without a quality system, complaint procedures or quality audits, according to an FDA warning letter.

The firm has not implemented any of its quality procedures in the past two years, “effectively operating without any quality system,” the letter said.

The company, which manufactures NeedleZap needle disintegration devices, has not performed quality audits or implemented its complaint procedure, corrective and preventive action procedure, nonconformance procedures or any other quality procedures for the past two years, the letter said.

The company could not be reached for comment by press time.

The warning letter can be seen at www.fda.gov/foi/warning_letters/s6597c.pdf.