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FDA Inspection
•AGC Pharma Chemicals Europe, S.L.U.•May 25, 2018

AGC Pharma Chemicals Europe, S.L.U. – FDA Inspection, May 25, 2018

Record Details

This FDA Inspection record concerns AGC Pharma Chemicals Europe, S.L.U., with an inspection on May 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
AGC Pharma Chemicals Europe, S.L.U.
Inspection Date
May 25, 2018
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • MRA McCulloughJ (Issuing Officer)
View Company Profile

ID · 3a42665b-48e2-437b-80d3-5a3eca9d7fba

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1159666
FDA center
Human Drugs
Project area
Drug Quality Assurance

Other FDA inspections of AGC Pharma Chemicals Europe, S.L.U.

5
DateClassificationOfficeProject area
May 16, 2024VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 20, 2023NAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
May 26, 2017Not classifiedOffice of Inspections and Investigations
September 25, 2015NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 16, 2009NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for AGC Pharma Chemicals Europe, S.L.U.
  • FDA Inspection 1276708 - 2024-05-16
  • FDA Inspection 1225598 - 2023-11-20
  • FDA Inspection 1016455 - 2017-05-26
  • FDA Inspection 943998 - 2015-09-25
  • FDA Inspection 601778 - 2009-07-16

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