483
Lac Mac LimitedLac Mac Limited – FDA 483, Apr 17, 2019
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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ID · 1bcddb20-66cb-409c-9500-7320a756e1b7
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