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# CGMP Issues Seen in Winder Laboratories Inspection
- URL: https://www.fdaweb.com/cgmp-issues-seen-in-winder-laboratories-inspection/
- Published: 2026-01-14T12:00:00.000Z
- Updated: 2026-09-14T15:30:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160488

A 7/14-8/5/2025 FDA inspection at the Winder Laboratories drug manufacturing facility in Winder, GA, found repeat significant violations of current good manufacturing practice (CGMP) regulations. A 1/7 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/winder-laboratories-llc-718601-01072026?ref=fdaweb.com) says the specific violations were:

- failure to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements, and failure to establish and follow adequate written procedures for cleaning and maintenance of equipment; and
- failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair.

The letter says FDA cited similar CGMP violations at inspections in 7/2018, 2/2022, and 2/2023\. “You proposed specific remediation for these observations in your response,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA says the firm’s quality systems are inadequate and recommends that Winder engage a qualified consultant to assist it in meeting CGMP requirements.

Winder was told to correct the violations promptly and to reply with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.