FDA Inspection
Zhejiang Anglikang Pharmaceutical Co., Ltd.Zhejiang Anglikang Pharmaceutical Co., Ltd. – FDA Inspection, Nov 21, 2025
Record Details
This FDA Inspection record concerns Zhejiang Anglikang Pharmaceutical Co., Ltd., with an inspection on November 21, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- November 21, 2025
- Product Type
- Human Drugs
View Company Profile
ID · e43561ac-a843-49fd-83ae-450ac020b9dd
Inspection Facts
- Inspection number
- 1292468
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
FDA Citations
8- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.80(d)Status of Each Lot Identified
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.