Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API)
Form 483 issued August 23, 2019 · Xianju, China
- Inspection
- Aug 20 – Aug 23, 2019
- Investigator
- Joel D. Hustedt
- Observations
- 1
- Pages
- 1
- FEI number
- 3003663256
In short: On August 23, 2019, FDA issued a Form 483 with 1 observation to Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API) in Xianju, Zhejiang (FEI 3003663256) after an inspection that ran Aug 20 – Aug 23, 2019. The investigator was Joel D. Hustedt. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The audit trails are not reviewed for the Anton Paar MCP 300 Polarimeter and the Metrohm…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API)?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API)?
Joel D. Hustedt is named on this Form 483, for the inspection of Aug 20 – Aug 23, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API) inspected by FDA?
The inspection ran Aug 20 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.
How do I get the full Form 483 for Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API)?
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.