483
Shriram Institute for Industrial ResearchFDA 483 - Shriram Institute for Industrial Research - October 22, 2019
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The FDA inspected Shriram Institute for Industrial Research in Delhi, India, a control testing laboratory, and found significant deficiencies. The firm failed to follow or establish written procedures for quality control, method verification, and electronic data management. These issues compromised data integrity, laboratory record-keeping, and the overall reliability of drug product testing.
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