FDA Inspection
SMC Costa Rica Division S.R.L.SMC Costa Rica Division S.R.L. – FDA Inspection, Jan 30, 2025
Record Details
This FDA Inspection record concerns SMC Costa Rica Division S.R.L., with an inspection on January 30, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- January 30, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 67387abf-e85b-44c0-9152-f2d7458aa546
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259544
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of SMC Costa Rica Division S.R.L.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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