Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
Form 483 issued September 13, 2024 · Qingpu, China
- Inspection
- Sep 9 – Sep 13, 2024
- Investigator
- Monica E. Murie
- Observations
- 3
- Pages
- 3
- FEI number
- 3005023997
In short: On September 13, 2024, FDA issued a Form 483 with 3 observations to Shanghai Chuangshi Medical Technology (Group) Co., Ltd. in Qingpu, Shanghai (FEI 3005023997) after an inspection that ran Sep 9 – Sep 13, 2024. The investigator was Monica E. Murie. Most observations concern laboratory controls and materials.
At a glance
Laboratory controls and materials account for 2 of 3 observations.
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 products does not include reliable, meaningful…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
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 firmShanghai Chuangshi Medical Technology (Group) Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shanghai Chuangshi Medical Technology (Group) Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, materials and production. The opening words of each observation are shown on this page.
Who inspected Shanghai Chuangshi Medical Technology (Group) Co., Ltd.?
Monica E. Murie is named on this Form 483, for the inspection of Sep 9 – Sep 13, 2024. Each investigator has a profile showing what they cite most.
When was Shanghai Chuangshi Medical Technology (Group) Co., Ltd. inspected by FDA?
The inspection ran Sep 9 – Sep 13, 2024, and the Form 483 is dated September 13, 2024.
How do I get the full Form 483 for Shanghai Chuangshi Medical Technology (Group) 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.