483
Mylan Laboratories LimitedFDA 483 - Mylan Laboratories Limited - April 12, 2018
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Record Details
An FDA inspection of Mylan Laboratories Limited in Sinnar, India, a drug product manufacturer, revealed significant deficiencies across its operations. Observations included failures in quality control unit procedures, inadequate investigation of production errors, and a lack of established written procedures for in-process controls. Additionally, the facility's building and employee amenities were found to be improperly maintained.
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ID · 4c91fbd7-6c18-41c4-8f08-ca2e411cd51b