Henan Kangdi Medical Devices Co. Ltd.
FDA inspection history in ZHOUKOU, China, 2019
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2019: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One close-out letter and one Form 483, at ZHOUKOU, China.
Cited most
Across all Henan Kangdi Medical Devices Co. observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.82Receipt and storage of untested components, drug product containers, and closures1
The complete Henan Kangdi Medical Devices Co. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
ZHOUKOU, China
One close-out letter and one Form 483 · 2019 · 7 observations
Latest: Close-out, Dec 3, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-03 | Close-out Close-out letter | ZHOUKOU, China | — | $99 |
| 2019-03-07 | 483 Form 483 | ZHOUKOU, China | 7 | $99 |
Investigators on these documents
FEI number 3009271465 · most recent document Dec 3, 2019
About Henan Kangdi Medical Devices Co. Ltd.
How many FDA Form 483s has Henan Kangdi Medical Devices Co. Ltd. received?
FDA Intel has 1 Form 483 on file for Henan Kangdi Medical Devices Co. Ltd.; the most recent is dated Mar 7, 2019.
When was Henan Kangdi Medical Devices Co. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Henan Kangdi Medical Devices Co. Ltd. is a Form 483 dated Mar 7, 2019, for the site in ZHOUKOU, China.
What did FDA cite at Henan Kangdi Medical Devices Co. Ltd.?
The regulations cited most in the observations on file for Henan Kangdi Medical Devices Co. Ltd. are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.166 (Stability testing), 1 time.