Dsquared Pharmaceuticals, Inc. – FDA Inspection, Feb 13, 2018

Record Details

This FDA Inspection record concerns Dsquared Pharmaceuticals, Inc., with an inspection on February 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Dsquared Pharmaceuticals, Inc.
Inspection Date: February 13, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Gloria J. Baca (FDA Associated Person)

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ID · 3f78e0df-112d-4df4-9ed0-2a363c5582e3

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1040843
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.68(b)Computer control of master formula records
21 CFR 211.142(b)Storage under appropriate conditions
21 CFR 211.25(a)GMP Training Frequency
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.22(a)Lack of quality control unit
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.180(e)(2)Items to cover on annual reviews
21 CFR 211.180(e)(1)Review of representative number of batches

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FDA Inspection

Dsquared Pharmaceuticals, Inc.February 13, 2018