Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.
Form 483 issued August 1, 2023 · Jinhua, China
- Inspection
- Jul 28 – Aug 1, 2023
- Investigator
- Rabea A. Hadeer
- Observations
- 4
- Pages
- 8
- FEI number
- 3003663281
In short: On August 1, 2023, FDA issued a Form 483 with 4 observations to Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. in Jinhua, Zhejiang (FEI 3003663281) after an inspection that ran Jul 28 – Aug 1, 2023. The investigator was Rabea A. Hadeer. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.42 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your pian fotled Po psrform…
- 02
Employers engopad m Ve monifa…
This inspection in context
Rabea A. Hadeer
1 document · 2023
Cites 211.25 (personnel qualifications) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Jinhua Conba Bio-Pharm. Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.?
Rabea A. Hadeer is named on this Form 483, for the inspection of Jul 28 – Aug 1, 2023. Each investigator has a profile showing what they cite most.
When was Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. inspected by FDA?
The inspection ran Jul 28 – Aug 1, 2023, and the Form 483 is dated August 1, 2023.
How do I get the full Form 483 for Zhejiang Jinhua Conba Bio-Pharm. 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.