FDA Inspection
Valgene Incorporated dba Cape DrugsValgene Incorporated dba Cape Drugs – FDA Inspection, Jan 22, 2018
Record Details
This FDA Inspection record concerns Valgene Incorporated dba Cape Drugs, with an inspection on January 22, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2e5ccdf7-04e1-4888-96da-7ea8d207d4aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038474
- 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 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Component identification test
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Other FDA inspections of Valgene Incorporated dba Cape Drugs
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 7, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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