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FDA Inspection
•Denmarks, LLC•April 11, 2012

Denmarks, LLC – FDA Inspection, Apr 11, 2012

Record Details

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

Company
Denmarks, LLC
Inspection Date
April 11, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 64af5c8a-f591-40da-b80c-e4a7739cb8b7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
777735
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.137(a)Expiration date lacking
  2. 21 CFR 211.22(a)Authority lacking to review records, investigate errors
  3. 21 CFR 211.192Investigations of discrepancies, failures

Full citation text and observation details available on the Dashboard.

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