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FDA Inspection
•Pekana Naturheilmittel GmbH•October 2, 2008

Pekana Naturheilmittel GmbH – FDA Inspection, Oct 2, 2008

Record Details

This FDA Inspection record concerns Pekana Naturheilmittel GmbH, with an inspection on October 2, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Pekana Naturheilmittel GmbH
Inspection Date
October 2, 2008
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 39c1bcd0-3c25-493e-a532-256fb196ef97

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
542411
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
  2. 21 CFR 211.130Procedures are written, and followed
  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 Pekana Naturheilmittel GmbH

5
DateClassificationOfficeProject area
October 10, 2024VAIDrug Quality Assurance
July 22, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 1, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 6, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 8, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Pekana Naturheilmittel GmbH
  • FDA Inspection 1302516 - 2024-10-10
  • FDA Inspection 1156199 - 2021-07-22
  • FDA Inspection 1054535 - 2018-06-01
  • FDA Inspection 981424 - 2016-05-06
  • FDA Inspection 826409 - 2013-03-08

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