FDA Inspection
Eagle TWE, INC.Eagle TWE, INC. – FDA Inspection, Oct 14, 2009
Record Details
This FDA Inspection record concerns Eagle TWE, INC., with an inspection on October 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eagle TWE, INC.
- Inspection Date
- October 14, 2009
- Product Type
- Devices
View Company Profile
ID · c890b0eb-b968-4547-9f6c-49bdd66e1ddc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 620286
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.30(b)Establish the design and development plan
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17Lack of Written MDR Procedures
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