Lonza AG
Form 483 issued March 29, 2019 · Visp, Switzerland
- Inspection
- Mar 25 – Mar 29, 2019
- Investigators
- Ralph M. Bernstein· Reyes Candau-Chacon
- Observations
- 5
- Pages
- 2
- FEI number
- 3002930340
In short: On March 29, 2019, FDA issued a Form 483 with 5 observations to Lonza AG in Visp, Switzerland (FEI 3002930340) after an inspection that ran Mar 25 – Mar 29, 2019. The investigators were Ralph M. Bernstein and Reyes Candau-Chacon. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing of the oo intermediate is inadequate. Identity testing of the? intermediate is conducted only upon…
- 02
Storage of A drug…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Storage and sampling of raw materials used for manufacture of 2 inside the)…
This inspection in context
Ralph M. Bernstein
10 documents · 2019–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
The firmLonza AG history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lonza AG?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Lonza AG?
Ralph M. Bernstein and Reyes Candau-Chacon are named on this Form 483, for the inspection of Mar 25 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was Lonza AG inspected by FDA?
The inspection ran Mar 25 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
How do I get the full Form 483 for Lonza AG?
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.