FDA Inspection
KAO USA IncKAO USA Inc – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns KAO USA Inc, with an inspection on April 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6d941a35-cff7-40e2-85c0-4966fa2c0d7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009150
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.194(e)Stability testing records not included
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Computer control of master formula records
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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 |
| January 25, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 23, 2010 | VAI | 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 768800 - 2012-01-25
- FDA Inspection 699294 - 2010-11-23
- FDA Inspection 581082 - 2009-04-27
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