BeOne Pharmaceutical (Suzhou) Co.,Ltd
Form 483 issued June 16, 2023 · Suzhou, China
- Observations
- 4
- Pages
- 2
- FEI number
- 3014150588
In short: On June 16, 2023, FDA issued a Form 483 with 4 observations to BeOne Pharmaceutical (Suzhou) Co.,Ltd in Suzhou, Jiangsu (FEI 3014150588). Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls used to release (6)(4) drug substance and drug product do not include scientifically sound…
- 02
Your firm has not fully established the accuracy, sensitivity, specificity, reproducibility of your HPLC method for…
- 03
Procedures applicable to your data integrity system are inadequate…
- 04
Procedures applicable to your…
This inspection in context
Questions about this 483
What did FDA find at BeOne Pharmaceutical (Suzhou) Co.,Ltd?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was BeOne Pharmaceutical (Suzhou) Co.,Ltd inspected by FDA?
This Form 483 is dated June 16, 2023.
How do I get the full Form 483 for BeOne Pharmaceutical (Suzhou) 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.