Stanmore Implants Worldwide, a manufacturer of extendable femur and knee-replacement devices, received an FDA warning letter for corrective and preventive action, complaint handling and auditing violations.
The Nov. 26 letter to the UK-based devicemaker says Stanmore’s CAPA procedures do not ensure that information is received by appropriate personnel.
The investigator also dinged the company’s corrective action procedures for not requiring documentation of CAPA activities. Investigators found a CAPA file closed as effective without confirming any corrective actions had been completed.
Another file, on corrective action to change plastic components related to the company’s ITAP prosthesis, did not contain adequate validation of the corrective action, the investigator found.
The FDA also criticizes the company’s complaint handling procedures, citing failure to evaluate complaints for MDR reportability, failure to document oral complaints upon receipt and failure to process complaints in a consistent and timely manner.
Further, the complaint handling procedure does not require that records of investigation include the nature of the complaint, device name and control number, or dates and results of the investigation, the letter says.
The FDA also rapped Stanmore’s quality audit system. According to the warning letter, the company violated a rule that auditors must not have responsibility for areas they audited in 2012 and 2013.
The FDA says that while Stanmore had revised these procedures since the July 2014 inspection, it remains unclear if personnel were trained in the new procedures and whether a retrospective review of complaints had been conducted.