FDA Inspection
SWISSCAPS Romania SRLSWISSCAPS Romania SRL – FDA Inspection, Feb 19, 2016
Record Details
This FDA Inspection record concerns SWISSCAPS Romania SRL, with an inspection on February 19, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SWISSCAPS Romania SRL
- Inspection Date
- February 19, 2016
- Product Type
- Drugs
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ID · 7a930ae0-988f-445d-b55e-ed5d9168d434
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 961288
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.194(a)(6)Comparison of Test Results to Specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of SWISSCAPS Romania SRL
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2024 | Not classified | Office of Inspections and Investigations | |
| August 27, 2024 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| August 21, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 11, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SWISSCAPS Romania SRL
- FDA Inspection 1264152 - 2024-10-11
- FDA Inspection 1248518 - 2024-08-27
- FDA Inspection 1102412 - 2019-08-21
- FDA Inspection 1124208 - 2018-05-11
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