Lonza Guangzhou Pharmaceutical Ltd. 68, Huangge Dadaobei
Form 483 issued October 31, 2025 · Nansha District, China
- Inspection
- Oct 31, 2025
- Investigator
- Jose M. Cayuela
- Observations
- 3
- Pages
- 2
- FEI number
- 3006532186
In short: On October 31, 2025, FDA issued a Form 483 with 3 observations to Lonza Guangzhou Pharmaceutical Ltd. 68, Huangge Dadaobei in Nansha District, Guangzhou Guangdong (FEI 3006532186) after an inspection that ran Oct 31, 2025. The investigator was Jose M. Cayuela. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities applicable to the quality unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure to of a…
- 03
The quality system that approves contract laboratories to perform testing…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLonza Guangzhou Pharmaceutical Ltd. 68, Huangge Dadaobei history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza Guangzhou Pharmaceutical Ltd. 68, Huangge Dadaobei?
FDA listed 3 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Lonza Guangzhou Pharmaceutical Ltd. 68, Huangge Dadaobei?
Jose M. Cayuela is named on this Form 483, for the inspection of Oct 31, 2025. Each investigator has a profile showing what they cite most.
When was Lonza Guangzhou Pharmaceutical Ltd. 68, Huangge Dadaobei inspected by FDA?
The inspection ran Oct 31, 2025, and the Form 483 is dated October 31, 2025.
How do I get the full Form 483 for Lonza Guangzhou Pharmaceutical Ltd. 68, Huangge Dadaobei?
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.