FDA Inspection
KAO USA IncKAO USA Inc – FDA Inspection, Nov 23, 2010
Record Details
This FDA Inspection record concerns KAO USA Inc, with an inspection on November 23, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- KAO USA Inc
- Inspection Date
- November 23, 2010
- Product Type
- Drugs
View Company Profile
ID · bfebe58c-ddcb-45f8-8a5a-e500b0bcd96a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699294
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of KAO USA Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2026 | Not classified | Cincinnati District Office | |
| May 24, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 27, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for KAO USA Inc
- FDA Inspection 1331758 - 2026-08-20
- FDA Inspection 1172639 - 2022-05-24
- FDA Inspection 1009150 - 2017-04-12
- FDA Inspection 768800 - 2012-01-25
- FDA Inspection 581082 - 2009-04-27
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