FDA Inspection
OPTILASA, S.L.OPTILASA, S.L. – FDA Inspection, Jun 2, 2010
Record Details
This FDA Inspection record concerns OPTILASA, S.L., with an inspection on June 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OPTILASA, S.L.
- Inspection Date
- June 2, 2010
- Product Type
- Devices
View Company Profile
ID · aea415f2-fd03-4be6-90a6-84ad1099b201
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 669185
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.70(a)(5)Criteria for workmanship
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
Showing 10 of 13 citations.
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Other FDA inspections of OPTILASA, S.L.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for OPTILASA, S.L.
- FDA Inspection 1182109 - 2022-10-27
- FDA Inspection 1045855 - 2018-02-01
- FDA Inspection 839603 - 2013-07-11
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