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FDA Inspection
•Antibioticos de Leon, SLU•January 20, 2017

Antibioticos de Leon, SLU – FDA Inspection, Jan 20, 2017

Record Details

This FDA Inspection record concerns Antibioticos de Leon, SLU, with an inspection on January 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Antibioticos de Leon, SLU
Inspection Date
January 20, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Alan P. Kurtzberg (FDA Associated Person)
View Company Profile

ID · 728eada7-bac2-4c18-81d6-a572dee4a2e5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1004228
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of Antibioticos de Leon, SLU

3
DateClassificationOfficeProject area
February 14, 2025Not classifiedOffice of Inspections and Investigations
October 18, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 21, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Antibioticos de Leon, SLU
  • FDA Inspection 1312258 - 2025-02-14
  • FDA Inspection 1099987 - 2018-10-18
  • FDA Inspection 744583 - 2011-07-21

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