Boehringer Ingelheim Biopharmaceuticals (China) Ltd.
Form 483 issued June 9, 2023 · Shanghai, China
- Observations
- 7
- Pages
- 6
- FEI number
- 3015009021
In short: On June 9, 2023, FDA issued a Form 483 with 7 observations to Boehringer Ingelheim Biopharmaceuticals (China) Ltd. in Shanghai, China (FEI 3015009021). Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality unit are not in…
- 02
Your firm has not established and followed appropriate visual inspection procedures designed to assure batches of…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Your firm failed to excise appropriate controls to protect the electronic data acquisition and/or manufacturing control…
This inspection in context
Questions about this 483
What did FDA find at Boehringer Ingelheim Biopharmaceuticals (China) Ltd.?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
When was Boehringer Ingelheim Biopharmaceuticals (China) Ltd. inspected by FDA?
This Form 483 is dated June 9, 2023.
How do I get the full Form 483 for Boehringer Ingelheim Biopharmaceuticals (China) 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.