FDA Inspection
OPTILASA, S.L.OPTILASA, S.L. – FDA Inspection, Oct 27, 2022
Record Details
This FDA Inspection record concerns OPTILASA, S.L., with an inspection on October 27, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OPTILASA, S.L.
- Inspection Date
- October 27, 2022
- Product Type
- Devices
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ID · dd7b124b-e318-44b4-9cca-736a2c79f1c6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1182109
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of OPTILASA, S.L.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 11, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 2, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for OPTILASA, S.L.
- FDA Inspection 1045855 - 2018-02-01
- FDA Inspection 839603 - 2013-07-11
- FDA Inspection 669185 - 2010-06-02
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