Wil Helmus schreef op 12 oktober 2018 23:04:
De fda is vaker op visite geweest bij pantheon
www.pharmacompass.com/fda-inspection-...Maar eigenlijk altijd 'no action indicated of voluntary action indicated'.
Volgens de fda:
NAI = No Action Indicated, meaning no objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not justify further action).
VAI = Voluntary Action Indicated, meaning objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action.
OAI = Official Action Indicated, meaning objectionable conditions were found and regulatory action should be recommended
Misschien nu Official Action Indicated?