FDA Inspection
Lenstec Barbados, Inc.Lenstec Barbados, Inc. – FDA Inspection, Apr 3, 2025
Record Details
This FDA Inspection record concerns Lenstec Barbados, Inc., with an inspection on April 3, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 2764ead3-dbd1-491c-baa9-0666133b3373
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1265912
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Lenstec Barbados, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 11, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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