Zhejiang Haisen Pharmaceutical Co., Ltd.
Form 483 issued April 11, 2018 · Dongyang, China
- Inspection
- Apr 6 – Apr 11, 2018
- Investigator
- Latorie S. Jones
- Observations
- 2
- Pages
- 3
- FEI number
- 3003967524
In short: On April 11, 2018, FDA issued a Form 483 with 2 observations to Zhejiang Haisen Pharmaceutical Co., Ltd. in Dongyang, Zhejiang (FEI 3003967524) after an inspection that ran Apr 6 – Apr 11, 2018. The investigator was Latorie S. Jones. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.194 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Validation Reports are not…
- 02
Complaints are not recorded, documented or investigated…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmZhejiang Haisen Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Haisen Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Zhejiang Haisen Pharmaceutical Co., Ltd.?
Latorie S. Jones is named on this Form 483, for the inspection of Apr 6 – Apr 11, 2018. Each investigator has a profile showing what they cite most.
When was Zhejiang Haisen Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Apr 6 – Apr 11, 2018, and the Form 483 is dated April 11, 2018.
How do I get the full Form 483 for Zhejiang Haisen 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.