Vancouver-based RS Medical was handed a 483 following a February inspection that found CAPA procedures and validation activities lacking. The company manufactures electrotherapy pain products.
The FDA found that only four out of 11 CAPA records from January 2014 to February 2016 were reviewed. One CAPA was opened “to address a systemic lack of understanding regarding storage requirements for rechargeable batteries” used in electrical nerve stimulation devices, the 483 says.
An action plan included revisions for material handling and storage and preservation, but it did not include charging requirements for the rechargeable batteries. In addition, the CAPA was closed but it didn’t include a verification check that the procedures were effective.
The 483 also cited the firm for not documenting software validation activities associated with the quality system.
Inspectors also found fault with the firm’s document control procedures and training activities. For example, changes to the device master record for the RS-41 Plus sequential stimulator were not approved through the document control procedures.
In addition, inspectors observed that the firm’s training activities lacked appropriate documentation. The firm’s SOP stipulates that new employees are assigned training by the department supervisor based on their responsibilities and that the training be completed in a timely manner.
But during the inspection, the investigator discovered that training records were dated the same day as the inspection for a quality assurance technician whose responsibilities include receiving, inspecting, quality testing and initiating out-of-specification reports.
RS Medical did not respond to a request for comment. Read the Form 483 here: www.fdanews.com/07-21-16-RSMedical483.pdf. — Tamra Sami