Boehringer Ingelheim Biopharmaceuticals (China) Ltd.
FDA inspection history in Shanghai, China, 2023
- 1
- EIR
- 1
- Form 483
Every document, by year
- EIR
- Form 483
2023: one inspection report and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One inspection report and one Form 483, at Shanghai, China.
Cited most
Across all Boehringer Ingelheim Biopharmaceuticals (China) observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Boehringer Ingelheim Biopharmaceuticals (China) 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
One Form 483 · 2023 · 7 observations
Latest: Form 483, Jun 9, 2023 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-09 | EIR EIR | — | — | $550 |
| 2023-06-09 | 483 Form 483 | Shanghai, China | 7 | $99 |
Investigators on these documents
FEI number 3015009021 · most recent document Jun 9, 2023
About Boehringer Ingelheim Biopharmaceuticals (China) Ltd.
How many FDA Form 483s has Boehringer Ingelheim Biopharmaceuticals (China) Ltd. received?
FDA Intel has 1 Form 483 on file for Boehringer Ingelheim Biopharmaceuticals (China) Ltd.; the most recent is dated Jun 9, 2023.
When was Boehringer Ingelheim Biopharmaceuticals (China) Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Boehringer Ingelheim Biopharmaceuticals (China) Ltd. is an establishment inspection report (EIR) dated Jun 9, 2023.
What did FDA cite at Boehringer Ingelheim Biopharmaceuticals (China) Ltd.?
The regulations cited most in the observations on file for Boehringer Ingelheim Biopharmaceuticals (China) Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.