Bio-Thera Solutions, Ltd.
FDA inspection history across 2 sites, 2023 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Two Form 483s, at Guangzhou, China and Huangpu Di strict, China.
- 2025The longest 483 on file: 5 observations over 9 pages at Huangpu Di strict, China.
Cited most
Across all Bio-Thera Solutions observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
The complete Bio-Thera Solutions file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Huangpu Di strict, China
One Form 483 · 2025 · 5 observations
Latest: Form 483, Jan 17, 2025 →Guangzhou, China
One Form 483 · 2023 · 2 observations
Latest: Form 483, Aug 18, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-17 | 483 Form 483 | Huangpu Di strict, China | 5 | $99 |
| 2023-08-18 | 483 Form 483 | Guangzhou, China | 2 | $99 |
Investigators on these documents
Jeanne Fringer (1)Jiangsong Jiang (1)Nozomi Sakakibara (1)Yiwei Li (1)
FEI number 3017231337 · most recent document Jan 17, 2025
About Bio-Thera Solutions, Ltd.
How many FDA Form 483s has Bio-Thera Solutions, Ltd. received?
FDA Intel has 2 Form 483s on file for Bio-Thera Solutions, Ltd.; the most recent is dated Jan 17, 2025.
When was Bio-Thera Solutions, Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Bio-Thera Solutions, Ltd. is a Form 483 dated Jan 17, 2025, for the site in Huangpu Di strict, China.
What did FDA cite at Bio-Thera Solutions, Ltd.?
The regulations cited most in the observations on file for Bio-Thera Solutions, Ltd. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.