FDA Inspection
ENG Scientific LLCENG Scientific LLC – FDA Inspection, Feb 24, 2009
Record Details
This FDA Inspection record concerns ENG Scientific LLC, with an inspection on February 24, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ENG Scientific LLC
- Inspection Date
- February 24, 2009
- Product Type
- Devices
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ID · c51ac8d0-020c-4786-bb64-6f8f2bbe8039
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 566751
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.198(a)General
- 21 CFR 820.25(b)Training records
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.181(a)DMR device specifications
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Other FDA inspections of ENG Scientific LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ENG Scientific LLC
- FDA Inspection 880568 - 2014-05-28
- FDA Inspection 780439 - 2012-05-09
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