by ComplianceQuest

My Dashboard Inspection Tracker FDA Guidance Templates Assessments

Sign in Get started

Tracker Overview Enforcement Themes Form 483s Warning Letters Inspections Recalls Investigators Companies Facilities

ANALYTICS

Tracker Overview Enforcement Themes

FDA ACTIONS

Form 483s Warning Letters Inspections Recalls

AUDIT READINESS

COMPANIES

Companies Facilities

Loading…

Dashboard Warning LettersWarning Letter Details

Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. Warning Letter Details

Warning Letter

Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.

Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd., Room 609, Building 6, no. 6 Ziyuan Road Huayuan High-tech Industrial Park Tianjin Shi , 300384 China, (b)(4)

Issue DateAugust 06, 2026

FEI Number3012560989

Violations1

CountryChina

Issuing Office

Center for Drug Evaluation and Research (CDER)

Product Type

Drugs

Status

Open

Subject

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded

Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. FDA Warning Letter, August 6, 2026