FDA Inspection
Lumene OyLumene Oy – FDA Inspection, Nov 29, 2013
Record Details
This FDA Inspection record concerns Lumene Oy, with an inspection on November 29, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lumene Oy
- Inspection Date
- November 29, 2013
- Product Type
- Drugs
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ID · eed8e8af-8599-4443-82f7-76331e2be5f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 856647
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.28(b)Habits of good sanitation & health
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.48(a)Potable water standards not met
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Lumene Oy
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lumene Oy
- FDA Inspection 1178846 - 2022-08-26
- FDA Inspection 981512 - 2016-06-17
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