FDA Inspection
Dermolab Pharma Ltd.Dermolab Pharma Ltd. – FDA Inspection, Oct 13, 2023
Record Details
This FDA Inspection record concerns Dermolab Pharma Ltd., with an inspection on October 13, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 673d4a87-0ca4-4516-9cd0-0d9dc48f3610
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220238
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Approve or reject components, products
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dermolab Pharma Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dermolab Pharma Ltd.
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.