Shanghai STA Pharmaceutical Product Co., Ltd.
FDA inspection history in Shanghai, China, 2021 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Shanghai, China.
- 2024One Form 483, at Shanghai, China.
- 2024The longest 483 on file: 3 observations over 4 pages at Shanghai, China.
Cited most
Across all Shanghai STA Pharmaceutical Product Co. observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.101Charge-in of components1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.56Sanitation1
The complete Shanghai STA Pharmaceutical Product Co. 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
Shanghai, China
Two Form 483s · 2021 to 2024 · 6 observations
Latest: Form 483, Jun 28, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-28 | 483 Form 483 | Shanghai, China | 3 | $99 |
| 2021-10-22 | 483 Form 483 | Shanghai, China | 3 | $99 |
FEI number 3014310427 · most recent document Jun 28, 2024
About Shanghai STA Pharmaceutical Product Co., Ltd.
How many FDA Form 483s has Shanghai STA Pharmaceutical Product Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Shanghai STA Pharmaceutical Product Co., Ltd.; the most recent is dated Jun 28, 2024.
When was Shanghai STA Pharmaceutical Product Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Shanghai STA Pharmaceutical Product Co., Ltd. is a Form 483 dated Jun 28, 2024, for the site in Shanghai, China.
What did FDA cite at Shanghai STA Pharmaceutical Product Co., Ltd.?
The regulations cited most in the observations on file for Shanghai STA Pharmaceutical Product Co., Ltd. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.101 (Charge-in of components), 1 time.