FDA Inspection
Daki, Ltee.Daki, Ltee. – FDA Inspection, Jan 16, 2019
Record Details
This FDA Inspection record concerns Daki, Ltee., with an inspection on January 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · cbf2b0a7-e12b-4566-889d-312937ef13db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076413
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Daki, Ltee.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Daki, Ltee.
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.