Irish Devicemaker’s 483 Notes Rusty Tables in Clean Room

Natus Manufacturing Limited, an Irish devicemaker, received an FDA Form 483 for slips related to acceptance activities and contamination-prevention procedures.

The FDA investigator observed rusty tables, cabinets and other equipment in the company’s clean room near the packaging area. The automated needle electrode assembly machine had “chipped paint all around its surface,” according to the form, recently released.

Natus also had multiple air microbial failures in the clean room in 2013 and in 2012, the form says.

In a second observation, the FDA notes Natus lacked statistical rationale to justify its sampling method for acceptance activities, including in-process inspection and finished device inspection for needle electrodes.

Natus did not respond to a request for comment by press time.

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