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# Advanced Pharmaceutical Repeat CGMP Violations
- URL: https://www.fdaweb.com/advanced-pharmaceutical-repeat-cgmp-violations/
- Published: 2025-03-18T12:00:00.000Z
- Updated: 2026-09-14T14:55:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158844

A 71/0-8/1/2024 FDA inspection at the Advanced Pharmaceutical Technology drug manufacturing facility in Elmsford, NY, found repeat significant violations of current good manufacturing practice (CGMP) regulations for combination products. A 3/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-pharmaceutical-technology-692576-03142025?ref=fdaweb.com) says specific violations were:

- failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all sterilization processes;
- failure to have, for each batch of controlled-release dosage form, appropriate laboratory determination of satisfactory conformance to the specifications for the rate of release of each active ingredient;
- failure 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
- failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

The letter says that while several of the firm’s products are listed in an agency database as being for export only, information obtained during the inspection indicated the firm plans to distribute the products commercially in the U.S. FDA cautions that based on the labeling, the products are legally considered to be new drugs that require FDA premarket approval.

FDA says it cited similar CGMP violations in 2019 and 2021 inspections and that the firm proposed specific remediation for them. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it says. Because Advanced failed to correct repeat violations, FDA says it should engage a qualified consultant to assist it in meeting CGMP requirements.

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.