Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.
Form 483 issued September 20, 2019 · Taizhou City, China
- Inspection
- Sep 16 – Sep 20, 2019
- Investigator
- G. Dissmeyer
- Observations
- 2
- Pages
- 2
- FEI number
- 3006545436
In short: On September 20, 2019, FDA issued a Form 483 with 2 observations to Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd. in Taizhou City, Zhejiang (FEI 3006545436) after an inspection that ran Sep 16 – Sep 20, 2019. The investigator was G. Dissmeyer. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Your firm failed to extend the validation to the full ran allowable in batch records, determined…
This inspection in context
G. Dissmeyer
1 document · 2019
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Hisoar Chuannan Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.?
G. Dissmeyer is named on this Form 483, for the inspection of Sep 16 – Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Sep 16 – Sep 20, 2019, and the Form 483 is dated September 20, 2019.
How do I get the full Form 483 for Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.