Hale Cosmeceuticals, Inc. – FDA Inspection, Jun 20, 2018

Record Details

This FDA Inspection record concerns Hale Cosmeceuticals, Inc., with an inspection on June 20, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Hale Cosmeceuticals, Inc.
Inspection Date: June 20, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Nicholas P. DiOrio (Company Rep)

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ID · c145acf9-d0bb-4f5e-8c44-d27f9e001981

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1056432
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.165(e)Test methods

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FDA Inspection

Hale Cosmeceuticals, Inc.June 20, 2018