The company will be submitting the responses to US FDA observations within stipulated timeline
The inspection concluded with no observations
Cipla has received 8 inspectional observations in Form 483
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)
The unit has filed 2 Derma products and 1 MDI product.
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
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