FDAnews
www.fdanews.com/articles/177704-capa-validation-failings-prompt-483-at-canadas-rs-medical

CAPA, Validation Failings Prompt 483 at Canada’s RS Medical

July 27, 2016

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. — Tamra Sami

View today's stories