Zhejiang Huahai Pharmaceutical Co. Ltd.
Form 483 issued June 28, 2019 · Linhai, China
- Inspection
- Jun 24 – Jun 28, 2019
- Investigator
- Jonathan W. Chapman
- Observations
- 5
- Pages
- 4
- FEI number
- 3003999190
In short: On June 28, 2019, FDA issued a Form 483 with 5 observations to Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, Zhejiang (FEI 3003999190) after an inspection that ran Jun 24 – Jun 28, 2019. The investigator was Jonathan W. Chapman. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
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…
- 02
Procedures designed to prevent…
- 03
Changes to written procedures are not…
- 04
control and…
This inspection in context
Jonathan W. Chapman
11 documents · 2014–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Huahai Pharmaceutical Co. Ltd. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
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 Huahai Pharmaceutical Co. Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Zhejiang Huahai Pharmaceutical Co. Ltd.?
Jonathan W. Chapman is named on this Form 483, for the inspection of Jun 24 – Jun 28, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Huahai Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Jun 24 – Jun 28, 2019, and the Form 483 is dated June 28, 2019.
How do I get the full Form 483 for Zhejiang Huahai 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.