FDA Inspection
Hisamitsu Pharmaceutical Co., Inc.Hisamitsu Pharmaceutical Co., Inc. – FDA Inspection, May 31, 2019
Record Details
This FDA Inspection record concerns Hisamitsu Pharmaceutical Co., Inc., with an inspection on May 31, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Caroline Strasinger (Issuing Officer)
- Saundrea A. Munroe (FDA Associated Person)
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ID · b9a8069f-a015-49e4-ab43-af820cc337fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091243
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.165(f)Failing drug products not rejected
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Other FDA inspections of Hisamitsu Pharmaceutical Co., Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 4, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| September 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 17, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 1, 2009 | NAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
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