FDA Inspection 1249416 - Aspen SA Sterile Operations (Pty) Ltd. - September 17, 2024

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Record Details

This FDA Inspection record concerns Aspen SA Sterile Operations (Pty) Ltd., with an inspection on September 17, 2024, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Aspen SA Sterile Operations (Pty) Ltd.
Inspection Date: September 17, 2024
Product Type: Human Drugs
Office: Office of Inspections and Investigations

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ID · 497b70c2-980b-462d-8d38-87f99e4c6003

Violation Codes10

21 CFR 211.100(a)21 CFR 211.11121 CFR 211.113(b)21 CFR 211.160(b)21 CFR 211.19221 CFR 211.194(a)21 CFR 211.28(a)21 CFR 211.42(c)(10)(iv)21 CFR 211.42(c)(10)(v)21 CFR 211.63

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