Shandong Xinhua Pharmaceutical Company Limited Hutian Branch
FDA inspection history in Zibo, 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 Zibo, China.
Cited most
Across all Shandong Xinhua Pharmaceutical Company Limited Hutian Branch observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Shandong Xinhua Pharmaceutical Company Limited Hutian Branch file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Zibo, China
One Form 483 · 2019 · 4 observations
Latest: Form 483, Mar 29, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-03-29 | 483 Form 483 | Zibo, China | 4 | $99 |
Investigators on these documents
FEI number 3004254526 · most recent document Mar 29, 2019
About Shandong Xinhua Pharmaceutical Company Limited Hutian Branch
How many FDA Form 483s has Shandong Xinhua Pharmaceutical Company Limited Hutian Branch received?
FDA Intel has 1 Form 483 on file for Shandong Xinhua Pharmaceutical Company Limited Hutian Branch; the most recent is dated Mar 29, 2019.
When was Shandong Xinhua Pharmaceutical Company Limited Hutian Branch last inspected by FDA?
The most recent FDA inspection document on file for Shandong Xinhua Pharmaceutical Company Limited Hutian Branch is a Form 483 dated Mar 29, 2019, for the site in Zibo, China.
What did FDA cite at Shandong Xinhua Pharmaceutical Company Limited Hutian Branch?
The regulations cited most in the observations on file for Shandong Xinhua Pharmaceutical Company Limited Hutian Branch are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.