The FDA is telling Health Science Products to get certification from an outside expert, after the company purchased components from unqualified suppliers.
The Hueytown, Ala., devicemaker lacked procedures to ensure purchased products conform to specifications, according to the Aug. 27 letter. HSP makes Class I dental chairs and dental operative units.
HSP must submit the consultant’s report, as well as certification by its own CEO that it has initiated or completed all corrections called for, by Feb. 1. Subsequent certifications of updated audits and corrections, if required, are due in 2016 and 2017.
HSP failed to establish a variety of other necessary procedures, including ones for medical device reporting and CAPA, according to the warning letter.
And the company failed to maintain device master records for its dental operative units and chairs. These records should include or refer to the site of all device, quality, production and process, packaging, labeling, and installation specifications, the warning letter says.
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