Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistMei Lan Thailand Co., Ltd., an active pharmaceutical ingredient (API) manufacturer in Thailand, was cited for manufacturing adulterated drugs under FDA regulations after the company repeatedly failed to respond to multiple inspection requests between May and August 2023, including four email notices, contact attempts to its U.S. Agent, and a written UPS delivery. The firm's refusal to permit FDA inspection of its facility violated Section 501(j) of the Federal Food, Drug, and Cosmetic Act, which prohibits drugs manufactured at establishments that delay, deny, limit, or refuse inspections. As enforcement action, the FDA placed the company on Import Alert 55-03 effective January 18, 2024, and warned it would withhold approval of new drug applications or supplements listing the firm as a manufacturer until the facility permits inspection and demonstrates CGMP compliance.