FDA Inspection
Safecross First Aid LtdSafecross First Aid Ltd – FDA Inspection, Jan 8, 2015
Record Details
This FDA Inspection record concerns Safecross First Aid Ltd, with an inspection on January 8, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Safecross First Aid Ltd
- Inspection Date
- January 8, 2015
- Product Type
- Devices
View Company Profile
ID · 0a747dc6-31fa-4c18-b48a-11e474b67706
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 910189
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Safecross First Aid Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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