483
Lac Mac LimitedFDA 483 - Lac Mac Limited - April 17, 2019
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Record Details
An FDA inspection of Lac Mac Limited, a medical device manufacturer in London, identified deficiencies in their quality system. Specifically, the firm's procedures for corrective and preventive action were found to be inadequately established. This included issues with inaccurate trending data for non-conformance reports and a lack of a written standard operating procedure for trending and analysis of quality data.
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