Hubei JXBio Pharmaceutical Co.,Ltd
Form 483 issued March 14, 2025 · Xianning, China
- Inspection
- Mar 10 – Mar 14, 2025
- Investigator
- Lisa R. Hilliard
- Observations
- 1
- Pages
- 2
- FEI number
- 3016784508
In short: On March 14, 2025, FDA issued a Form 483 with 1 observation to Hubei JXBio Pharmaceutical Co.,Ltd in Xianning, Hubei (FEI 3016784508) after an inspection that ran Mar 10 – Mar 14, 2025. The investigator was Lisa R. Hilliard. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations and Out-of-Specifications (OOS) are not clearly documented, explained, or investigated…
This inspection in context
Lisa R. Hilliard
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmHubei JXBio Pharmaceutical 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hubei JXBio Pharmaceutical Co.,Ltd?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hubei JXBio Pharmaceutical Co.,Ltd?
Lisa R. Hilliard is named on this Form 483, for the inspection of Mar 10 – Mar 14, 2025. Each investigator has a profile showing what they cite most.
When was Hubei JXBio Pharmaceutical Co.,Ltd inspected by FDA?
The inspection ran Mar 10 – Mar 14, 2025, and the Form 483 is dated March 14, 2025.
How do I get the full Form 483 for Hubei JXBio 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.