FDA Inspection
Asanuma CorporationAsanuma Corporation – FDA Inspection, Jun 15, 2018
Record Details
This FDA Inspection record concerns Asanuma Corporation, with an inspection on June 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 63200781-499d-46f4-8130-b28a51de0e26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055830
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
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Other FDA inspections of Asanuma Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Asanuma Corporation
- FDA Inspection 771622 - 2012-01-26
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