FDA Inspection

Regenesis Pharmaceutical Inc.June 18, 2019

Regenesis Pharmaceutical Inc. – FDA Inspection, Jun 18, 2019

Record Details

This FDA Inspection record concerns Regenesis Pharmaceutical Inc., with an inspection on June 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Regenesis Pharmaceutical Inc.
Inspection Date: June 18, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Alan L. Truong

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ID · 394e483e-0160-4b5b-924c-97fa756a7c00

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1093423
FDA center: Human Drugs
Project area: Unapproved and Misbranded Drugs
Outcome: Form 483 issued

FDA Citations

21 CFR 211.188Prepared for each batch, include complete information
21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.25(a)Training--operations, GMPs, written procedures
21 CFR 211.198(a)Procedures to be written and followed
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.125(a)Strict control not exercised over labeling issued
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.84(d)(1)Identity Testing of Each Component
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.22(d)Procedures not in writing, fully followed

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