Cardinal Health 414, LLC – FDA Inspection, Aug 3, 2018

Record Details

This FDA Inspection record concerns Cardinal Health 414, LLC, with an inspection on August 3, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Cardinal Health 414, LLC
Inspection Date: August 3, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Claire M. Minden (Investigator)

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ID · 8a9844e8-acc2-4497-a5aa-f6929ebb18b7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1060958
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 212.30(b)Equipment procedures
21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination

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FDA Inspection

Cardinal Health 414, LLCAugust 3, 2018