JNTL Consumer Health (India) Private Limited – FDA 483, Apr 17, 2024
JNTL Consumer Health (India) Private Limited, a control testing laboratory in Mumbai, India, received a Form 483 with two observations. The inspection revealed deficiencies in the routine inspection and impact assessment of electronic equipment, leading to unexplained failures and potential data loss. Additionally, the facility failed to justify deviations from written laboratory mechanisms, specifically regarding its preventative maintenance program and the timely closure of investigations and corrective actions.
ID · 9fe62af7-ed03-48b9-9103-e39f3f36652d
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