Can I read Jacobus Pharmaceutical Inspection Report on EtoBox?
Jacobus Pharmaceutical Inspection Report by vinay is a document available to read on EtoBox.
What is Jacobus Pharmaceutical Inspection Report about?
This was a comprehensive cGMP inspection of a manufacturer of active pharmaceutical ingredients and prescription drugs. Inspectional findings included: the failure to adequately perform failure investigations, inadequate cleaning of manufacturing equipment, and failure to maintain facilities and equipment in a state of repair. An FDA Form 483 was issued citing deficiencies including a lack of manufacturing controls and failure to validate methods. The firm was advised that its response to the Form 483
- Author
- vinay
- Language
- EN