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# CGMP Violations at Australia’s Delta Laboratories
- URL: https://www.fdaweb.com/cgmp-violations-at-australias-delta-laboratories/
- Published: 2018-01-16T12:00:00.000Z
- Updated: 2026-09-14T23:13:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140496

A 3/27-3/31/17 FDA inspection at Delta Laboratories Pty. Ltd., Somersby, Australia, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/19/17 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm591826.htm?ref=fdaweb.com). Specific violations cited in the letter were: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
- failing to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates.

The firm’s 4/13/17 response to the inspection observations was inadequate in that it failed to provide sufficient evidence that the company was taking corrective actions to bring its operation into full compliance with CGMP.

“Significant findings in this letter indicate that your quality unit is not fully exercising its authority and/or responsibilities,” FDA says. “Your firm must provide the quality unit with appropriate authority, sufficient resources, and staff to carry out its responsibilities and consistently ensure drug quality.” The letter also reiterates the firm’s responsibility as a contract drug production facility regardless of agreements in place with product owners.

The agency recommends that the firm retain a qualified consultant to assist it with comprehensive remediation of its facilities, methods, controls, and quality systems to ensure they comply with CGMP requirements. It asks that the consultant give FDA a detailed report describing its efforts. Delta was placed on an import alert 9/28/17.

The company was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.