FDA Inspection
Taizhou Kangping Medical Science And Technology Co., Ltd.Taizhou Kangping Medical Science And Technology Co., Ltd. – FDA Inspection, Mar 14, 2025
Record Details
This FDA Inspection record concerns Taizhou Kangping Medical Science And Technology Co., Ltd., with an inspection on March 14, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- March 14, 2025
- Product Type
- Human Drugs
View Company Profile
ID · 162722d1-13cd-45b3-9c89-9b8d756207a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1265725
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(1)Sample size - test intervals
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Taizhou Kangping Medical Science And Technology Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Taizhou Kangping Medical Science And Technology Co., Ltd.
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.