Chroma Research Labs, Inc. – FDA Inspection, Jan 10, 2018

Record Details

This FDA Inspection record concerns Chroma Research Labs, Inc., with an inspection on January 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Chroma Research Labs, Inc.
Inspection Date: January 10, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Alice S. Tsao (FDA Associated Person)

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ID · 9e01d8c6-c7ba-4c24-8c0b-8baa8313c8e9

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1037761
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.165(e)Test methods

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FDA Inspection

Chroma Research Labs, Inc.January 10, 2018