FDA Inspection
Infantino LLCInfantino LLC – FDA Inspection, Aug 7, 2013
Record Details
This FDA Inspection record concerns Infantino LLC, with an inspection on August 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Infantino LLC
- Inspection Date
- August 7, 2013
- Product Type
- Devices
View Company Profile
ID · 53144e93-f5e4-4bdd-800d-3477b2fe3200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843372
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.40(b)Document changes, review and approval, communication
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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Other FDA inspections of Infantino LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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