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Medical Devices / Inspections and Audits

Nursing Home Supply Manufacturer Cited for Contamination Procedures

March 8, 2019

Failure to identify actions needed to correct and prevent microbial contamination landed Nurses Assist a Form 483 from the FDA following an Oct. 15 to Oct. 25, 2018 inspection of the firm’s Haltom City, Texas facility.

The maker of senior care products for institutions launched and closed investigations into at least 32 nonconformances due to bioburden issues since July 2017 but didn’t establish procedures to confirm that corrective actions were effective.

For example, the manufacturer failed to validate the effect of a sterilization process for sterile water and saline bottles that were packaged in tracheostomy care kits.

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