Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory
Form 483 issued March 7, 2025 · Xinchang, China
- Inspection
- Mar 4 – Mar 7, 2025
- Investigators
- Monica E. Murie· Victoria Spivak
- Observations
- 1
- Pages
- 2
- FEI number
- 3003631275
In short: On March 7, 2025, FDA issued a Form 483 with 1 observation to Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory in Xinchang, Zhejiang (FEI 3003631275) after an inspection that ran Mar 4 – Mar 7, 2025. The investigators were Monica E. Murie and Victoria Spivak. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program for drug substances has not been validated…
This inspection in context
Monica E. Murie
11 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
The firmZhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. 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 Medicine Co., Ltd. Xinchang Pharmaceutical Factory?
Monica E. Murie and Victoria Spivak are named on this Form 483, for the inspection of Mar 4 – Mar 7, 2025. Each investigator has a profile showing what they cite most.
When was Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory inspected by FDA?
The inspection ran Mar 4 – Mar 7, 2025, and the Form 483 is dated March 7, 2025.
How do I get the full Form 483 for Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical Factory?
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.