FDA Inspection
Life-Tech, IncLife-Tech, Inc – FDA Inspection, Mar 3, 2009
Record Details
This FDA Inspection record concerns Life-Tech, Inc, with an inspection on March 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Life-Tech, Inc
- Inspection Date
- March 3, 2009
- Product Type
- Devices
View Company Profile
ID · a49eaef5-bfab-4a17-b143-dcb7e8a9aaf2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 566226
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 820.100(a)(3)Identifying corrective & preventive actions
- 21 CFR 820.100(a)(4)Verification vs validation
- 21 CFR 820.50(a)(2)Supplier oversight
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