Mr. Hongzhi Li
CEO
Yiling Pharmaceutical Ltd.
No. 36 Zhujiang Street
Shijiazhuang Shi
Hebei Sheng , 050035
ChinaFEI 3011640199Issued Mar 27, 2025Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011640199.
Violations2
Issue DateMar 27, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Yiling Pharmaceutical Ltd.
Location
Mr. Hongzhi Li
CEO
Yiling Pharmaceutical Ltd.
No. 36 Zhujiang Street
Shijiazhuang Shi
Hebei Sheng , 050035
China
FEI Number
3011640199
Country
China
Issue Date
March 27, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Yiling Pharmaceutical Ltd., a Chinese drug manufacturer, received a warning for significant Current Good Manufacturing Practice (CGMP) violations in finished pharmaceutical production. FDA inspectors found that the company's non-dedicated manufacturing equipment was not properly designed or maintained to prevent cross-contamination, including failures to ensure tight seals on ducts and inadequate control of residues from multiple drug products—including therapeutic agents—that were manufactured on the same equipment with degraded seals covered only with tape. The facility's methods, facilities, and controls do not conform to CGMP regulations under 21 CFR parts 210 and 211, rendering the drug products adulterated under the Federal Food, Drug, and Cosmetic Act.
Yiling Pharmaceutical Ltd. FDA Warning Letter, March 27, 2025