FDA Intel

Hubei JXBio Pharmaceutical Co.,Ltd

Form 483 issued August 30, 2024 · Xianning, China

Inspection
Aug 30, 2024
Observations
3
Pages
3
FEI number
3016784508

In short: On August 30, 2024, FDA issued a Form 483 with 3 observations to Hubei JXBio Pharmaceutical Co.,Ltd in Xianning, Hubei (FEI 3016784508) after an inspection that ran Aug 30, 2024. Most observations concern quality system and facilities & equipment.

At a glance

Quality system and facilities & equipment account for 2 of 3 observations.

Quality system1
Facilities & equipment1
Production1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.25

    The personnel are not properly trained in their particular job functions and records…

  2. 02
    21 CFR 211.67

    Equipment cleaning procedure has…

  3. 03
    21 CFR 211.110

    Examination and testing of samples is not done to assure that in-process…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The firm

Hubei JXBio Pharmaceutical Co.,Ltd history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.25

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 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.

When was Hubei JXBio Pharmaceutical Co.,Ltd inspected by FDA?

The inspection ran Aug 30, 2024, and the Form 483 is dated August 30, 2024.

How do I get the full Form 483 for Hubei JXBio Pharmaceutical Co.,Ltd?

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