FDA has concluded that this inspection is 'closed'
The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
InvaGen has received 5 inspectional observations in Form 483
Eris Lifesciences enters into term loan agreement with Citi Bank
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Cipla has received 8 inspectional observations in Form 483
The RTP manufacturing facility will support the company's clinical studies and early commercial launch in North America and Europe
The facility will supply clinical trial materials for the development of vaccines and biologics up to Phase II stage and is expected to be fully operational by early 2023.
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