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FDA Inspection
•Pratt Midwest Display LLC•April 26, 2017

Pratt Midwest Display LLC – FDA Inspection, Apr 26, 2017

Record Details

This FDA Inspection record concerns Pratt Midwest Display LLC, with an inspection on April 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Pratt Midwest Display LLC
Inspection Date
April 26, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Heather A. McCauley (FDA Associated Person)
  • Lauren N. Howard (FDA Associated Person)
View Company Profile

ID · 936d5236-6dc8-4324-9478-5b6d87e89d14

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1009116
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 211.68(b)Written record not kept of program and validation data
  2. 21 CFR 211.188(b)(6)Inspection of packaging and labeling area

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pratt Midwest Display LLC

3
DateClassificationOfficeProject area
March 1, 2016NAICenter for Food Safety and Applied NutritionFood and Color Additives Petition Review
August 10, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 23, 2009NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Pratt Midwest Display LLC
  • FDA Inspection 963737 - 2016-03-01
  • FDA Inspection 739510 - 2011-08-10
  • FDA Inspection 616611 - 2009-09-23

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