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FDA Inspection
•CPI Packaging, Inc.•April 16, 2009

CPI Packaging, Inc. – FDA Inspection, Apr 16, 2009

Record Details

This FDA Inspection record concerns CPI Packaging, Inc., with an inspection on April 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company
CPI Packaging, Inc.
Inspection Date
April 16, 2009
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 71141e71-836d-4abc-80c2-412cba98b6f5

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
576522
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

7
  1. 21 CFR 820.198(a)General
  2. 21 CFR 820.25(b)Training
  3. 21 CFR 820.20Management responsibility
  4. 21 CFR 820.90(a)Specific non-conforming product procedures
  5. 21 CFR 820.184Lack of or inadequate DHR procedures
  6. 21 CFR 820.100(a)Lack of or inadequate procedures
  7. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

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