Sun Pharma's Halol in Gujarat issued with 3 observations by US FDA Form 483
Sun Pharma's Halol in Gujarat issued with 3 observations by US FDA Form 483
US FDA conducted Good Manufacturing Practices (GMP) inspection of Sun Pharma's Halol facility from Feb'12 - 23. It didn't disclose the nature of these observations.A Form 483 is issued by the US FDA inspectors at the end of the inspection outlining any deviations from GMP. Sun Pharma, India's largest drug maker.
Sun Pharma, India's largest drug maker on Friday said US FDA has issued three Form 483 observations for its Halol site in Gujarat.
The company didn't disclose the nature of these observations.
A Form 483 is issued by the US FDA inspectors at the end of the inspection outlining any deviations from GMP.
The US FDA conducted Good Manufacturing Practices (GMP) inspection of Sun Pharma's Halol facility from February 12 - 23. Ref. : http://www.moneycontrol.com/news/business/companies/us-fda-issues-form-483-for-sun-pharmas-halol-facility-in-gujarat-with-3-observations-2514693.html --- Dated: Feb'23,2018.
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