483
SHILPA MEDICARE LIMITEDFDA 483 - SHILPA MEDICARE LIMITED - May 29, 2026
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Record Details
Shilpa Medicare Limited in Bengaluru, India, a drug manufacturer, was cited for significant deficiencies across its quality systems, including inadequate process validation and failure to thoroughly investigate discrepancies. The firm also lacked complete production records, appropriate controls over computer systems, and proper equipment hold time studies.
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