The FDA has banned imports of Doro’s Evacu B wheeled stretchers for infants, after a Nov. 10-13, 2014, inspection found serious GMP violations related to the device.
An FDA spokesman confirmed that all devices from Ottawa, Canada-based Doro have been placed under detention without examination, which prohibits devices that have not met GMPs from entering the U.S.
Doro manufactures security devices and wheeled stretchers for infants and adults. The company’s website says the Evacu B is the only neonatal hospital evacuation chair that requires only one nurse to move six babies from a neonatal intensive care unit.
The violations were noted in the November inspection and Form 483. The company must provide a written response describing corrections planned or undertaken within 15 days to lift the ban.
The investigator cited Doro for not including specifications for the device or its production process, including production methods, procedures and environment specifications, in its device master record. The DMR also lacked quality assurance procedures and specifications, including acceptance criteria, a March 9 warning letter says.
Also missing from the DMR were packaging and labeling specifications and procedures for installation, servicing and maintenance.
Doro also lacked records on evaluations of custom component suppliers. Although the firm revised its evaluation procedures, the process still lacks requirements for evaluating suppliers for quality and removing them when necessary and doesn’t provide for ongoing supplier evaluation, the warning letter says.
Doro’s design control procedures also came in for a hit. According to the investigator, the design history file for the Evacu B lacks records for reviewed or approved design inputs or verification. Requirements for addressing ambiguous or conflicting design input requirements also are missing.
The company further failed to ensure that equipment is routinely calibrated and checked. Doro’s procedures say that special devices are calibrated before each use, but don’t define how the calibration is performed.
The FDA also found that tools used for in-process and finished device testing were in use before the inspection, but were not calibrated until the last day of the inspection. Doro also has no record of nonconforming product or rework activities and no requirement for investigation of nonconforming product, the warning letter says.
Doro President Douglas Gervais tells IDDM the company has hired outside consultants to address the administrative issues in the warning letter. Read it at www.fdanews.com/04-21-15-Doro.pdf. — Charlotte Astor