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Medical Devices / Inspections and Audits

Cirrus Healthcare Cited for Procedural Issues

Oct. 8, 2018

The FDA hit East Dorset, Vermont, manufacturer Cirrus Healthcare with a Form 483 over procedural violations.

The agency, during its April 24-26 inspection, found that the firm could not provide its product acceptance of silicone regarding the correct additives and proper quantities, which was required by one of its acceptance activities procedures.

The firm also failed to adequately maintain one of its device master records, as it was unable to provide the DMR specification for the chemical makeup of silicone material used in the firm’s ultra-soft silicone products.

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