Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.
Form 483 issued January 26, 2018 · Jinhua, China
- Inspection
- Jan 22 – Jan 26, 2018
- Investigator
- Michael A. Charles
- Observations
- 4
- Pages
- 3
- FEI number
- 3003663281
In short: On January 26, 2018, 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 Jan 22 – Jan 26, 2018. The investigator was Michael A. Charles. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are not always complete…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate procedures designed to assure…
- 03
Validation does not always include full establishment of process parameters. a) Regarding cleaning validation, written procedures…
- 04
Equipment cleaning and maintenance…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.67
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 quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.?
Michael A. Charles is named on this Form 483, for the inspection of Jan 22 – Jan 26, 2018. 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 Jan 22 – Jan 26, 2018, and the Form 483 is dated January 26, 2018.
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.