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FDA Inspection
•Quest Diagnostics Inc. at Lovelace Medical Center•May 20, 2014

Quest Diagnostics Inc. at Lovelace Medical Center – FDA Inspection, May 20, 2014

Record Details

This FDA Inspection record concerns Quest Diagnostics Inc. at Lovelace Medical Center, with an inspection on May 20, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Quest Diagnostics Inc. at Lovelace Medical Center
Inspection Date
May 20, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · c1811cb1-a20a-4c50-b685-398ef233b150

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
879392
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
  2. 21 CFR 606.100(b)(13)Procedures to relate blood from donor to final disposition
  3. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Quest Diagnostics Inc. at Lovelace Medical Center

1
DateClassificationOfficeProject area
January 23, 2009NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Quest Diagnostics Inc. at Lovelace Medical Center
  • FDA Inspection 564153 - 2009-01-23

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