Zhejiang Huahai Pharmaceutical Co. Ltd.
Form 483 issued May 31, 2019 · Linhai, China
- Inspection
- May 20 – May 31, 2019
- Investigators
- Jonathan W. Chapman· Zedong Dong
- Observations
- 6
- Pages
- 5
- FEI number
- 3003999190
In short: On May 31, 2019, FDA issued a Form 483 with 6 observations to Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, Zhejiang (FEI 3003999190) after an inspection that ran May 20 – May 31, 2019. The investigators were Jonathan W. Chapman and Zedong Dong. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate validation of the analytical methods used for testing of API, Crude API by GC-MS…
- 02
Your firm lacks a scientifically sound cleaning validation program for…
- 03
Your firm has not fully evaluated…
- 04
Your procedure for the identification of…
This inspection in context
Jonathan W. Chapman
11 documents · 2014–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmZhejiang Huahai Pharmaceutical Co. Ltd. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Huahai Pharmaceutical Co. Ltd.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Zhejiang Huahai Pharmaceutical Co. Ltd.?
Jonathan W. Chapman and Zedong Dong are named on this Form 483, for the inspection of May 20 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was Zhejiang Huahai Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran May 20 – May 31, 2019, and the Form 483 is dated May 31, 2019.
How do I get the full Form 483 for Zhejiang Huahai 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.