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FDA Inspection
•Libra Technical Center, LLC•May 11, 2012

Libra Technical Center, LLC – FDA Inspection, May 11, 2012

Record Details

This FDA Inspection record concerns Libra Technical Center, LLC, with an inspection on May 11, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Libra Technical Center, LLC
Inspection Date
May 11, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 8ea381f9-8dd7-412a-a266-c8f7b3b8b7f7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
781416
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.194(a)(2)Statement of methods and data
  2. 21 CFR 211.180(c)Records not made readily available to FDA
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Libra Technical Center, LLC

1
DateClassificationOfficeProject area
December 5, 2008NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Libra Technical Center, LLC
  • FDA Inspection 549846 - 2008-12-05

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