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FDA Inspection
•Oakwood Laboratories LLC•July 13, 2009

Oakwood Laboratories LLC – FDA Inspection, Jul 13, 2009

Record Details

This FDA Inspection record concerns Oakwood Laboratories LLC, with an inspection on July 13, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Oakwood Laboratories LLC
Inspection Date
July 13, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 492a9284-a296-4201-97ef-18e2fe141e15

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
596075
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

1
  1. 21 CFR 211.100(b)SOPs not followed / documented

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Oakwood Laboratories LLC

5
DateClassificationOfficeProject area
October 8, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 17, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 15, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 20, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 13, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Oakwood Laboratories LLC
  • FDA Inspection 1107325 - 2019-10-08
  • FDA Inspection 1080045 - 2019-01-17
  • FDA Inspection 878894 - 2014-05-15
  • FDA Inspection 799244 - 2012-09-20
  • FDA Inspection 720009 - 2011-04-13

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