FDA Inspection
Daito Pharmaceutical Co., Ltd.Daito Pharmaceutical Co., Ltd. – FDA Inspection, Dec 19, 2023
Record Details
This FDA Inspection record concerns Daito Pharmaceutical Co., Ltd., with an inspection on December 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · f70a2428-1ef7-45a6-abe8-c8a8e761bbab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1226666
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Daito Pharmaceutical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2017 | Not classified | Office of Inspections and Investigations | |
| September 29, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Daito Pharmaceutical Co., Ltd.
- FDA Inspection 1180850 - 2022-09-16
- FDA Inspection 1037107 - 2017-11-10
- FDA Inspection 748400 - 2011-09-29
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.