Canadian Devicemaker Can’t Sell in U.S. Due to GMP Violations
The FDA banned imports of Doro’s Evacu B wheeled stretchers for infants, after a Nov. 10 to 13, 2014, inspection found serious GMP violations that were noted in a Form 483 to the company.
The investigator cited the Ottawa, Canada, company for not having 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, and packaging and labeling specifications and procedures for installation, servicing and maintenance, a March 9 warning letter says.
Further, Doro’s design history file lacked records for reviewed or approved design inputs or verification. Requirements for addressing ambiguous or conflicting design input requirements also were missing. According to the investigator, the firm failed to ensure equipment is routinely calibrated and checked. Doro’s procedures say 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 weren’t calibrated until the last day of the inspection.
Doro President Douglas Gervais says the company has hired outside consultants to address the administrative issues in the warning letter.
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