FDA Inspection
Germiphene CorporationGermiphene Corporation – FDA Inspection, May 24, 2018
Record Details
This FDA Inspection record concerns Germiphene Corporation, with an inspection on May 24, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 48d1d854-5177-4987-888d-a1d1c00f267d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056647
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Germiphene Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Germiphene Corporation
- FDA Inspection 962166 - 2016-02-19
- FDA Inspection 777994 - 2012-03-16
- FDA Inspection 671773 - 2010-06-24
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