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FDA Inspection
•Pharmpur Gmbh•July 15, 2014

Pharmpur Gmbh – FDA Inspection, Jul 15, 2014

Record Details

This FDA Inspection record concerns Pharmpur Gmbh, with an inspection on July 15, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Pharmpur Gmbh
Inspection Date
July 15, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · db405772-a7e6-44f4-a818-43b78244ad12

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
887312
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls
  2. 21 CFR 211.113(b)Procedures for sterile drug products
  3. 21 CFR 211.110(a)Written in-process control procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pharmpur Gmbh

5
DateClassificationOfficeProject area
June 18, 2024VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 15, 2018Not classifiedOffice of Inspections and Investigations
June 7, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 13, 2011VAICenter for Devices and Radiological HealthRadiation Control and Health Safety Act
July 16, 2009VAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for Pharmpur Gmbh
  • FDA Inspection 1244161 - 2024-06-18
  • FDA Inspection 1075253 - 2018-11-15
  • FDA Inspection 988103 - 2016-06-07
  • FDA Inspection 748525 - 2011-09-13
  • FDA Inspection 601626 - 2009-07-16

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