FDA Inspection
Havels IncHavels Inc – FDA Inspection, Dec 19, 2012
Record Details
This FDA Inspection record concerns Havels Inc, with an inspection on December 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Havels Inc
- Inspection Date
- December 19, 2012
- Product Type
- Devices
View Company Profile
ID · 43bf3910-416c-4a60-9a48-4a8e26deaa68
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811692
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Havels Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 26, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Havels Inc
- FDA Inspection 1073429 - 2018-11-26
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