Suzhou Union Biopharm Co., Ltd.
Form 483 issued May 26, 2023 · Suzhou, China
- Inspection
- May 15 – May 26, 2023
- Investigators
- Li Lane Christensen· Wendy G. Tan· Ying-Xin Fan
- Observations
- 3
- Pages
- 2
- FEI number
- 3014164694
In short: On May 26, 2023, FDA issued a Form 483 with 3 observations to Suzhou Union Biopharm Co., Ltd. in Suzhou, Jiangsu (FEI 3014164694) after an inspection that ran May 15 – May 26, 2023. The investigators were Li Lane Christensen, Wendy G. Tan and Ying-Xin Fan. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to prevent microbiological contaminations of the drug product purporting to be sterile are inadequate ar…
- 02
Responsibilities and quality oversight of the…
- 03
Written procedures are inadequate…
This inspection in context
Li Lane Christensen
1 document · 2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in China.
The firmSuzhou Union Biopharm Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Suzhou Union Biopharm Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Suzhou Union Biopharm Co., Ltd.?
Li Lane Christensen, Wendy G. Tan and Ying-Xin Fan are named on this Form 483, for the inspection of May 15 – May 26, 2023. Each investigator has a profile showing what they cite most.
When was Suzhou Union Biopharm Co., Ltd. inspected by FDA?
The inspection ran May 15 – May 26, 2023, and the Form 483 is dated May 26, 2023.
How do I get the full Form 483 for Suzhou Union Biopharm Co., Ltd.?
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