FDA Inspection
Space Maintainers LabSpace Maintainers Lab – FDA Inspection, Apr 12, 2012
Record Details
This FDA Inspection record concerns Space Maintainers Lab, with an inspection on April 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Space Maintainers Lab
- Inspection Date
- April 12, 2012
- Product Type
- Devices
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ID · 891ebc46-9150-4dc8-8840-e09211c47319
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778599
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Space Maintainers Lab
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2024 | NAI | Los Angeles District Office | Postmarket Assurance: Medical Devices |
| September 17, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 10, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 2, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Space Maintainers Lab
- FDA Inspection 1250841 - 2024-10-03
- FDA Inspection 1153252 - 2021-09-17
- FDA Inspection 1028477 - 2017-10-10
- FDA Inspection 875507 - 2014-04-10
- FDA Inspection 650328 - 2010-03-02
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