FDA Inspection
Shiseido America Inc.Shiseido America Inc. – FDA Inspection, Nov 1, 2018
Record Details
This FDA Inspection record concerns Shiseido America Inc., with an inspection on November 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8162c83c-f99b-43e4-9c70-c6f70901d4d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070566
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Shiseido America Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2024 | VAI | New Jersey District Office | Drug Quality Assurance |
| January 26, 2017 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| May 13, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| November 24, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Shiseido America Inc.
- FDA Inspection 1254656 - 2024-12-03
- FDA Inspection 1002794 - 2017-01-26
- FDA Inspection 877354 - 2014-05-13
- FDA Inspection 776775 - 2012-04-12
- FDA Inspection 633380 - 2009-11-24
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