FDA Inspection
Glasir Medical, LPGlasir Medical, LP – FDA Inspection, Jun 28, 2017
Record Details
This FDA Inspection record concerns Glasir Medical, LP, with an inspection on June 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ad73c6ad-a226-44ce-8f5c-6ff43ba1a946
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016248
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 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(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Glasir Medical, LP
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 29, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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