Steritech Pty Ltd. – FDA Inspection, Nov 10, 2023

Record Details

This FDA Inspection record concerns Steritech Pty Ltd., with an inspection on November 10, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Steritech Pty Ltd.
Inspection Date: November 10, 2023
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Margaret M. Annes (FDA Associated Person)

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ID · 8ae2863a-30e0-46c6-9628-1683595855a7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1222421
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.160(b)(4)Establishment of calibration procedures
21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 211.160(b)(4)Establishment of calibration procedures
21 CFR 211.68(a)Calibration/Inspection/Checking not done

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FDA Inspection

Steritech Pty Ltd.November 10, 2023