FDA Inspection
Daki, Ltee.Daki, Ltee. – FDA Inspection, Sep 14, 2016
Record Details
This FDA Inspection record concerns Daki, Ltee., with an inspection on September 14, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Daki, Ltee.
- Inspection Date
- September 14, 2016
- Product Type
- Drugs
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ID · f40594b7-c9f1-45eb-bfb0-fae3f90afcda
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986768
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Daki, Ltee.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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