FDA Inspection
Glaropharm AgGlaropharm Ag – FDA Inspection, May 31, 2023
Record Details
This FDA Inspection record concerns Glaropharm Ag, with an inspection on May 31, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4567f4cb-ff69-4522-845c-71eba3c7dcc5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1207105
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Glaropharm Ag
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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