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# Safecor Health CGMP Violations
- URL: https://www.fdaweb.com/safecor-health-cgmp-violations/
- Published: 2023-09-12T12:00:00.000Z
- Updated: 2026-09-14T18:55:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155301

A 3/7-3/16 FDA inspection at the Safecor Health drug manufacturing facility in Woburn, MA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/5 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safecor-health-llc-657886-09052023?ref=fdaweb.com) says specific violations were:

- failing to adequately inspect the packaging and labeling facilities immediately before use to assure that all drug products have been removed from the previous operations;
- failing to establish and follow adequate written procedures for cleaning and maintaining equipment;
- failing to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA recommends that the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The consultant should perform a comprehensive six-system audit of the company’s entire operation for CGMP compliance, FDA says, and should evaluate the completion and efficacy of its corrective and preventive actions before it pursues resolution of its compliance status with FDA.

Safecor was told to correct the 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.