Insufficient Training, Contamination Highlight Latest Form 483 for Allied Medical

Unclean assembly areas, incomplete repair data sheets, no documentation of service manager training and water damage with insects throughout the facility are but a sampling of observations in a Form 483 the FDA levied on medical device manufacturer Allied Medical of St. Louis.

An agency inspection conducted last autumn at the company’s St. Louis manufacturing facility uncovered seven observations, and mirrors similar issues found during an inspection of the same location 18 months earlier.

The company’s product line includes nebulizers, ventilators and related respiratory devices for hospital and in-home use.

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