FDA Inspection
Stellar Medical LLC.Stellar Medical LLC. – FDA Inspection, Jun 27, 2012
Record Details
This FDA Inspection record concerns Stellar Medical LLC., with an inspection on June 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stellar Medical LLC.
- Inspection Date
- June 27, 2012
- Product Type
- Devices
View Company Profile
ID · bd962252-2fb9-4c2c-80f2-68f17a506825
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788024
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(h)Use and removal, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Stellar Medical LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 14, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Stellar Medical LLC.
- FDA Inspection 891591 - 2014-07-11
- FDA Inspection 818922 - 2013-02-14
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