The FDA has cited four device firms for a range of compliance and quality issues, including serious problems arising with failed devices and the steps companies take when devices break, are returned or fail completely.
An inspection over the first week of February at Davol in Warwick, R.I. revealed problems with reporting the malfunction of a device that could cause injury or death. Davol, a subsidiary of Bard, never submitted a medical device report after being made aware of the problem, according to the Form 483.
Investigators said that complaints regarding the possible failure of a device and the failure of the labeling and packaging to meet stated specifications were never investigated by the company.
Problems included a failure to review device history files. The firm failed to review all relevant information about the failed products, for example the device history files and retained samples from the same lot, and failed to replicate the failures with the actual or similar devices, according to the inspector’s observations.
Candela Corp.: On a February visit to the Candela Corp. facility in Wayland, Mass., the agency found that in 2016, the device maker did not submit a medical device report within 30 days of notification that a device on the market had malfunctioned and would be likely to cause or contribute to death or serious injury if the malfunction were to reoccur. An MDR was filed, but not within the required time frame.
Inspectors also found improperly labeled and stored returned product going back as far as 2011 and a lack of CAPA documentation on corrective actions possibly going back as far as 2014.
EQM Research: Inspectors found no process validations on equipment used to manufacture medical devices at the EQM Research facility in Cheviot, Ohio, including revalidations after moving equipment to a new location over the past four to five years.
There were also no established procedures for receiving, reviewing and evaluating complaints for MDR reportablity. The president of the company told inspectors he had never received a customer complaint and there were no complaint files, according to the From 483, though inspectors found a customer complaint from a 2003 email that was never recorded as a complaint.
No MDR procedures had been established at the company, and the facility lacked any corrective and preventative action procedures, methodology for quality audits, supplier quality device history records been established or maintained, the FDA inspectors said.
Kub Technologies: Documents and procedures were decidedly lacking at the Kub Technologies facility in Stratford, Conn., according to a Form 483. The X-ray cabinet manufacturer lacked device master records, labeling instructions and user manuals. The investigators found no device history records, no way of instructing employees on steps for quality inspection, testing and acceptance work, and no established procedures for reworking devices that did not meet quality standards.
There were also no established procedures for receiving, reviewing and evaluating complaints for MDR reportablity. In numerous cases, there was no clear indication of an investigation into or follow up on returned devices or customer calls and complaints, inspectors noted.
Four or 15 nonconforming reports, used as records of investigations into devices sent back to the firm as a result of customer complaints, did not clearly indicate an investigation of activities related to the original complaint.