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# Aspen Pharmacare CGMP Violations
- URL: https://www.fdaweb.com/aspen-pharmacare-cgmp-violations/
- Published: 2025-03-19T12:00:00.000Z
- Updated: 2026-09-14T14:55:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158851

A 9/9-9/17/2024 FDA inspection at the Aspen Pharmacare drug manufacturing facility in Korsten, Gqeberha, South Africa, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/24 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aspen-pharmacare-holdings-limited-701671-02242025?ref=fdaweb.com) says the specific violations were:

- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failure to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records; and
- failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

FDA reminded Aspen it is responsible for the quality of drugs it produces as a contract facility regardless of agreements in place with product owners. The agency acknowledged that the firm had engaged a consultant to assist it in meeting CGMP requirements and acknowledged its commitment to suspend producing drugs for the U.S. market. Aspen is to notify FDA if it plans to resume any regulated manufacturing operations.

Aspen’s products were placed on an FDA Import Alert on 2/10\. The company was told to correct any violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.