LONZA BIOLOGICS TUAS PTE. LTD.
Form 483 issued June 18, 2019 · Singapore, Singapore
- Inspection
- Jun 10 – Jun 18, 2019
- Investigators
- Madushini Dharmasena· Sarah Johnson· Viviana Matta
- Observations
- 2
- Pages
- 2
- FEI number
- 3009725845
In short: On June 18, 2019, FDA issued a Form 483 with 2 observations to LONZA BIOLOGICS TUAS PTE. LTD. in Singapore, Singapore (FEI 3009725845) after an inspection that ran Jun 10 – Jun 18, 2019. The investigators were Madushini Dharmasena, Sarah Johnson, Viviana Matta and Yanming An. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures in place are inadequate to prevent the use of defective material for the…
- 02
Corrective actions did not include implementation of adequate procedures to prevent…
This inspection in context
Madushini Dharmasena
13 documents · 2019–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmLONZA BIOLOGICS TUAS PTE. LTD. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LONZA BIOLOGICS TUAS PTE. LTD.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected LONZA BIOLOGICS TUAS PTE. LTD.?
Madushini Dharmasena, Sarah Johnson, Viviana Matta and Yanming An are named on this Form 483, for the inspection of Jun 10 – Jun 18, 2019. Each investigator has a profile showing what they cite most.
When was LONZA BIOLOGICS TUAS PTE. LTD. inspected by FDA?
The inspection ran Jun 10 – Jun 18, 2019, and the Form 483 is dated June 18, 2019.
How do I get the full Form 483 for LONZA BIOLOGICS TUAS PTE. 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.