FDA Inspection
Novum Pharma, LLCNovum Pharma, LLC – FDA Inspection, Sep 24, 2019
Record Details
This FDA Inspection record concerns Novum Pharma, LLC, with an inspection on September 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · e7687eb8-6d1e-48e7-adbe-92ee0bead8a5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1102732
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 310.305(c)(2)Investigation of serious, unexpected events
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.