LNK International, Inc. – FDA 483, Oct 28, 2025

An FDA inspection of LNK International, Inc., a drug product manufacturer in Hauppauge, NY, was conducted from October 22 to October 28, 2025. The inspection revealed several significant observations documented on an FDA Form 483, indicating deviations from current Good Manufacturing Practice regulations under the Federal Food, Drug, and Cosmetic Act.

Key issues identified included deficiencies in laboratory controls, specifically the failure to perform growth promotion testing for commercially purchased media plates, with the firm relying solely on vendor certificates of analysis. Equipment and utensils were also not cleaned at appropriate intervals, with documented instances where dirty hold times exceeded established limits for manufacturing equipment. Additionally, the firm failed to thoroughly investigate 43 product complaints received from 2024 to 2025 regarding missing lot numbers and expiry dates on distributed drug products. These investigations were not extended to retain samples or distributed batches, and the firm had not implemented adequate corrective and preventive actions to prevent recurrence.

LNK International, Inc. is required to provide a comprehensive response detailing its proposed corrective and preventive actions to address these observations and ensure regulatory compliance.