Zhejiang Jingwei Pharmaceutical Co., Ltd.
Form 483 issued March 15, 2019 · Quzhou, China
- Inspection
- Mar 5 – Mar 15, 2019
- Investigator
- Huckleberry Kong
- Observations
- 7
- Pages
- 3
- FEI number
- 3010166839
In short: On March 15, 2019, FDA issued a Form 483 with 7 observations to Zhejiang Jingwei Pharmaceutical Co., Ltd. in Quzhou, China (FEI 3010166839) after an inspection that ran Mar 5 – Mar 15, 2019. The investigator was Huckleberry Kong. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures desavibing the handkin of all written and. ora] Complaints, regocching @ . Product’ shail…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Huckleberry Kong
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 Jingwei Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Jingwei Pharmaceutical Co., Ltd.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Zhejiang Jingwei Pharmaceutical Co., Ltd.?
Huckleberry Kong is named on this Form 483, for the inspection of Mar 5 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Jingwei Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Mar 5 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Zhejiang Jingwei 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.