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FDA Inspection
•CKD Bio Corporation•October 26, 2018

CKD Bio Corporation – FDA Inspection, Oct 26, 2018

Record Details

This FDA Inspection record concerns CKD Bio Corporation, with an inspection on October 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
CKD Bio Corporation
Inspection Date
October 26, 2018
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Jose A. Cruz Gonzalez
View Company Profile

ID · a171cc5b-8308-48b2-8e6e-929b61e9d5b6

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1069932
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

Other FDA inspections of CKD Bio Corporation

5
DateClassificationOfficeProject area
November 7, 2025VAIDrug Quality Assurance
September 15, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 18, 2022NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 17, 2015NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 8, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for CKD Bio Corporation
  • FDA Inspection 1299998 - 2025-11-07
  • FDA Inspection 1287766 - 2023-09-15
  • FDA Inspection 1195625 - 2022-11-18
  • FDA Inspection 956322 - 2015-12-17
  • FDA Inspection 773987 - 2012-03-08

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