FDA Inspection
Lumene OyLumene Oy – FDA Inspection, Aug 26, 2022
Record Details
This FDA Inspection record concerns Lumene Oy, with an inspection on August 26, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lumene Oy
- Inspection Date
- August 26, 2022
- Product Type
- Drugs
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ID · f7a13e1e-9b56-4743-b0e3-1bbaf6a9c734
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1178846
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lumene Oy
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 29, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lumene Oy
- FDA Inspection 981512 - 2016-06-17
- FDA Inspection 856647 - 2013-11-29
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