483
Emcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited – FDA 483, Apr 5, 2024
Record Details
Emcure Pharmaceuticals Limited in Charal, Gujarat, India, was inspected from March 28 to April 5, 2024. The inspection revealed one observation concerning the firm's failure to establish and follow procedures for instrument calibration and preventive maintenance for microbiological testing equipment. This issue impacts the reliability and accuracy of microbiological test results, as the firm relies solely on vendor qualification.
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ID · c3e711b2-4931-42d8-9332-9ae339e29fb4
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