British devicemaker EMcision received an FDA warning letter for medical device reporting failures, inadequate CAPA procedures and other issues.
According to the Nov. 20 warning letter posted online Tuesday, the company failed to develop, maintain and implement written MDR procedures. For example, the procedures omit the definition of the term “become aware,” which could result in an incorrect decision when evaluating a complaint to see if it meets reporting criteria. The company also failed to specify who on staff decides to report events to the FDA, the letter says.
EMcision’s procedures also lack instructions for completing MDRs in a timely matter and for how documentation and record-keeping requirements will be addressed, the letter adds. In an Aug. 29 response to a Form 483, EMcision said it would revise its MDR procedure and submit a copy, but the agency never received one, the letter says. The warning letter followed an Aug. 11 to 14, 2014, inspection.
EMcision also failed to maintain complaint files, process complaints in a uniform and timely manner, document oral complaints and evaluate them to determine if they needed to be reported to the FDA.
Investigators reviewed all eight CAPAs initiated between 2009 and 2013 and found that all were missing some documentation, contained conflicting information or had no signatures, the warning letter says.
Further, the company failed to follow document management procedures and didn’t establish and maintain procedures for identifying, documenting and validating design changes for its Habib EndoHPB endoscopic bipolar radio frequency probe.