Shanghai Henlius Biologics Co.,Ltd
Form 483 issued August 4, 2023 · Shanghai, China
- Inspection
- Jul 26 – Aug 4, 2023
- Observations
- 4
- Pages
- 2
- FEI number
- 3023420030
In short: On August 4, 2023, FDA issued a Form 483 with 4 observations to Shanghai Henlius Biologics Co.,Ltd in Shanghai, Songjiang District (FEI 3023420030) after an inspection that ran Jul 26 – Aug 4, 2023. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's procedure for verifying the absence of (b) (4) for the (b) (4) fill line…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Procedures for facility microbial…
- 04
Procedures supporting the (b) (4) Test Method of (b) (4) lack…
This inspection in context
Questions about this 483
What did FDA find at Shanghai Henlius Biologics Co.,Ltd?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The opening words of each observation are shown on this page.
When was Shanghai Henlius Biologics Co.,Ltd inspected by FDA?
The inspection ran Jul 26 – Aug 4, 2023, and the Form 483 is dated August 4, 2023.
How do I get the full Form 483 for Shanghai Henlius Biologics Co.,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.