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FDA Inspection
•CSL Plasma, Inc.•January 17, 2012

CSL Plasma, Inc. – FDA Inspection, Jan 17, 2012

Record Details

This FDA Inspection record concerns CSL Plasma, Inc., with an inspection on January 17, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
CSL Plasma, Inc.
Inspection Date
January 17, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · a578ccc3-a6fa-41df-a6ce-80addaaefb1c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
764129
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 606.60(a)Equipment observed, standardized, calibrated
  2. 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 CSL Plasma, Inc.

6
DateClassificationOfficeProject area
October 21, 2022NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 26, 2017VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 19, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 5, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 2, 2011VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for CSL Plasma, Inc.
  • FDA Inspection 1182014 - 2022-10-21
  • FDA Inspection 1029879 - 2017-10-26
  • FDA Inspection 961840 - 2016-02-19
  • FDA Inspection 868764 - 2014-03-05
  • FDA Inspection 744589 - 2011-09-02

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