Bio-Thera Solutions, Ltd.
Form 483 issued January 17, 2025 · Huangpu Di strict, China
- Inspection
- Jan 7 – Jan 17, 2025
- Investigators
- Jeanne Fringer· Jiangsong Jiang· Nozomi Sakakibara
- Observations
- 5
- Pages
- 9
- FEI number
- 3017231337
In short: On January 17, 2025, FDA issued a Form 483 with 5 observations to Bio-Thera Solutions, Ltd. in Huangpu Di strict, China (FEI 3017231337) after an inspection that ran Jan 7 – Jan 17, 2025. The investigators were Jeanne Fringer, Jiangsong Jiang, Nozomi Sakakibara and Yiwei Li. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Written procedures for production and process controls designed to assure that the drug product has the…
- 04
Adequate procedural controls were not established to protect the electronic data acquisition and process control systems…
- 05
Observation 5: scanned text, readable in the full document.
This inspection in context
Jeanne Fringer
6 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmBio-Thera Solutions, 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bio-Thera Solutions, Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Bio-Thera Solutions, Ltd.?
Jeanne Fringer, Jiangsong Jiang, Nozomi Sakakibara and Yiwei Li are named on this Form 483, for the inspection of Jan 7 – Jan 17, 2025. Each investigator has a profile showing what they cite most.
When was Bio-Thera Solutions, Ltd. inspected by FDA?
The inspection ran Jan 7 – Jan 17, 2025, and the Form 483 is dated January 17, 2025.
How do I get the full Form 483 for Bio-Thera Solutions, 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.