483
Chromo Laboratories India Private LimitedChromo Laboratories India Private Limited – FDA 483, Aug 10, 2024
Record Details
Chromo Laboratories India PVT. LTD. in Patancheru Mandel, India, was inspected and received a Form 483 with 9 observations. The inspection revealed significant deficiencies across quality control, quality unit oversight, equipment maintenance, record management, environmental controls, and employee training. These issues indicate a systemic failure to adhere to GMP requirements for the manufacture and storage of intermediates and APIs.
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ID · 49ae002d-51b0-4d95-ab93-249ae7340d14
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