Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)
FDA inspection history in Wenzhou, China, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Wenzhou, China.
Cited most
Across all Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) observations on file
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Wenzhou, China
One Form 483 · 2019 · 3 observations
Latest: Form 483, Mar 22, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-03-22 | 483 Form 483 | Wenzhou, China | 3 | $99 |
Investigators on these documents
FEI number 3010728912 · most recent document Mar 22, 2019
About Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)
How many FDA Form 483s has Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) received?
FDA Intel has 1 Form 483 on file for Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant); the most recent is dated Mar 22, 2019.
When was Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) last inspected by FDA?
The most recent FDA inspection document on file for Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) is a Form 483 dated Mar 22, 2019, for the site in Wenzhou, China.
What did FDA cite at Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant)?
The regulations cited most in the observations on file for Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) are 21 CFR 211.182 (Equipment cleaning and use log), 1 time; 21 CFR 211.25 (Personnel qualifications), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.