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FDA Inspection
•Praxair Distribution, Inc.•August 22, 2014

Praxair Distribution, Inc. – FDA Inspection, Aug 22, 2014

Record Details

This FDA Inspection record concerns Praxair Distribution, Inc., with an inspection on August 22, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Praxair Distribution, Inc.
Inspection Date
August 22, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 9b9e5261-c7a9-41a8-9509-5dd1b695c0ee

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
893725
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

6
  1. 21 CFR 211.44Adequate lighting not provided
  2. 21 CFR 211.105(a)Identification of containers, lines, equipment
  3. 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
  4. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  5. 21 CFR 211.142(a)Quarantine - actual practice
  6. 21 CFR 211.180(e)(1)Review of representative number of batches

Full citation text and observation details available on the Dashboard.

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