MSN Laboratories Private Ltd.June 23, 2016

FDA 483 - MSN Laboratories Private Ltd. - June 23, 2016

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Record Details

MSN Laboratories Private Limited in Telangana, India, an Active Pharmaceutical Ingredient (API) manufacturer, was cited for significant quality system deficiencies. Observations included a failure to investigate numerous instances of invalid HPLC/GC analysis and reprocessed chromatograms, as well as inadequate control over temperature-sensitive raw materials. Additionally, the firm failed to ensure appropriate transport and storage conditions for APIs shipped internationally to the US market.

Company: MSN Laboratories Private Ltd.
Inspection Date: June 23, 2016
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Doan T. Nguyen (Microbiologist )

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ID · b1bf84da-4acd-4e7e-af4a-f75dea2a3e1d